Q2 2025 Upcoming FDA Decision Dates (PDUFAs)

Q2 2025 Upcoming FDA Decision Dates (PDUFAs)

As we enter the second half of 2025, it’s important to keep apprised of the upcoming FDA approval dates for new drugs. The decisions made on these dates will be key to understanding the industry’s trajectory during the remainder of the year.

Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in the second quarter of 2025:

 
PDUFA Date COMPANY NAME   Orphan Drug Indication
04-02-25 Aldeyra Therapeutics, Inc.   Reproxalap Dry eye disease
04-02-25 Novartis   Vanrafia (atrasentan) IgA nephropathy
04-03-25 Exelixis, Inc.   CABOMETYX Advanced neuroendocrine tumors
04-03-25 Amgen Inc.   Uplizna Immunoglobulin G4-related disease
04-10-25 argenx SE   VYVGART SC pre-filled syringe Generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy
04-21-25 Bristol-Myers Squibb Co.   Nivolumab plus ipilimumab Hepatocellular carcinoma (HCC)
04-26-25 Telix Pharmaceuticals Limited   TLX101-CDx imaging of glioma
04-29-25 Abeona Therapeutics   Prademagene zamikeracel (pz-cel) Recessive Dystrophic Epidermolysis Bullosa
04-29-25 Stealth BioTherapeutics   Elamipretide Barth syndrome
04-30-25 Johnson & Johnson   Nipocalimab Generalized myasthenia gravis
05-07-25 GSK    Nucala Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
05-19-25 Novavax Inc.   NVX-CoV2705 (Nuvaxovid) COVID-19 vaccine for individuals aged 12 to 64 years with at least one underlying condition, such as asthma, cancer, diabetes, obesity, or smoking
05-22-25 Arcutis Biotherapeutics Inc.   ZORYVE (roflumilast)  Scalp and body psoriasis in adults and adolescents ages 12 and over
05-24-25 Liquidia Corporation   Yutrepia Pulmonary arterial hypertension
05-26-25 Merck   WELIREG (belzutifan) Advanced Pheochromocytoma and Paraganglioma (PPGL)
05-28-25 Eton Pharmaceuticals, Inc   ET-400  Pediatric adrenal insufficiency
05-31-25 Moderna   mRNA-1283 Respiratory COVID-19 vaccine
06-10-25 Merck    Clesrovimab RSV Disease
06-12-25 Moderna, Inc   mRNA-1345 Respiratory syncytial virus (RSV) vaccine in high-risk adults aged 18-59
06-13-25 UroGen Pharma Ltd.   UGN-102 Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
06-17-25 KalVista Pharmaceuticals, Inc.   Sebetralstat Hereditary Angioedema
06-19-25 Gilead Sciences Inc.   Lenacapavir HIV prevention
06-20-25 Sanofi & Regeneron    Dupixent Bullous Pemphigoid
06-20-25 GSK    Shingrix Shingles (herpes zoster).
06-23-25 Nuvation Bio    Taletrectinib Advanced ROS1-positive non-small cell lung cancer
06-23-25 Merck & Co Inc.   Keytruda (pembrolizumab) Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
06-28-25 Unicycive Therapeutics, Inc.   Oxylanthanum Carbonate Hyperphosphatemia in patients with Chronic Kidney Disease on Dialysis
06-30-25 Verastem, Inc.   Avmapki Fakzynja Co-Pack KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC)
How Are NIH Funding Cuts Shaping the Future of U.S. Biomedicine?

How Are NIH Funding Cuts Shaping the Future of U.S. Biomedicine?

Author:  Tara Smylie

The Trump administration’s recent decision to cap the National Institutes of Health (NIH) indirect cost reimbursements at 15% has sent ripples throughout the biomedical and life sciences communities. While advocates argue that this change redirects more money toward direct research, many biomedical professionals – from university deans to laboratory scientists – have warned that the broader effects may be far more damaging than anticipated. As the U.S. seeks to maintain its global leadership in biomedical innovation, these funding changes raise tricky questions about sustainability, competitiveness, and career direction within the field.

Nuts and Bolts: What Does a 15% Overhead Cap Mean for Biomedical Research?

At the heart of this controversy lies a misunderstanding of what “indirect costs” really are. These are not superfluous or wasteful expenditures – they are the administrative, infrastructural, and regulatory frameworks that enable direct research to function. This includes expenses like lab maintenance, building utilities, equipment, IT infrastructure, and regulatory compliance. According to BBC, institutions typically recoup around 30% of grant value in indirect costs – sometimes more. With this figure slashed in half, universities and research hospitals are forced to absorb significant expenses.

Dr. David Skorton, CEO of the Association of American Medical Colleges, put it plainly: “These are real costs. They are reimbursement for audited, real costs.” He warned that the most dire downstream effect would be a slowdown or halt in the pace of scientific discovery, depriving Americans of new treatments and diagnostics.

In practice, institutions will likely have to shut down some labs, reduce support staff, and scale back on infrastructure. Scientists at elite research institutions like Stanford and Johns Hopkins are already seeing signs of this. Dr. Theodore Iwashyna of Johns Hopkins warns that even computational tools – vital for data-driven medical modeling – are at risk. “If we can’t keep the computers running, we can’t do the science,” he said.

Private philanthropic foundations, often pointed to by conservative groups like the Heritage Foundation as alternatives to government funding, typically operate on different terms. While private foundations may cap indirect costs at 10%, they also often allow direct charges for certain expenses the government excludes. Furthermore, their funds are limited, and they rarely support the full ecosystem of biomedical infrastructure the NIH sustains.

While the Trump administration has framed the cuts as an efficiency measure – and Musk’s Department of Government Efficiency (DOGE) has supported the idea, claiming that some universities use up to 60% of grant money for overhead – the reality is more nuanced. STAT News has noted that institutions with large endowments do not necessarily use them to offset research costs, as these funds are often restricted.

If the U.S. is to remain competitive in global biomedicine, preserving the integrity of the research environment – which includes both people and infrastructure – is essential.

The Outlook for Candidates

Early-career researchers and postdoctoral fellows are likely to feel the sting of these cuts first. With indirect cost funding slashed, institutions may reduce the number of new hires or even begin laying off support staff. This creates a more competitive and uncertain academic job market.

But there may be a silver lining: as academic institutions tighten their belts, candidates may find themselves increasingly drawn toward private-sector roles. Biotech firms, pharmaceutical companies, and startups, particularly those with robust funding from venture capital, may offer not only more stability but also better compensation packages and clearer growth paths.

Indeed, some scientists are already exploring options abroad or with private firms. A recruiter’s market is emerging for candidates with translational or interdisciplinary experience, especially those who can bridge the lab bench and the business office.

To stay competitive and adaptable, candidates should consider broadening their skill sets. At present, skills sets like bioinformatics, regulatory affairs, product development, and clinical trial management are all in-demand. On the employer side, institutions can support current and potential hires by offering professional development in non-academic skills and forging new industry partnerships.

The Outlook for Employers

For private-sector employers, the indirect cost cap presents both a challenge and an opportunity. In the short term, if academic research institutions begin to weaken, partnerships forged with them may be disrupted. Academic-industry collaborations often serve as pipelines for innovation, and a contraction in university-based research could put a damper on early-stage discovery.

On the other hand, private companies may benefit from an increased talent pool and more hiring dynamics that skew in their favor. Scientists disillusioned with academic prospects may be more willing to consider industry roles that they previously touted as a backup plan. By the same token, employers may find highly skilled candidates with prestigious research backgrounds newly open to corporate R&D or hybrid roles.

This shift away from university-powered research could also stimulate growth in contract research organizations (CROs) and private research labs, which may be seen as more financially agile and less dependent on government structures. Employers should prepare by investing in onboarding and mentorship programs tailored to former academics, ensuring that cultural transitions are smooth and productive.

Finally, companies positioned to offer some of the “indirect” infrastructure – cloud-based lab management, regulatory consulting, or scientific instrumentation – may see a surge in demand from downsized university labs looking for scalable, cost-efficient alternatives.

The Long-Term Outlook – and Navigating the New Normal

While the near-term outlook remains challenging across the board, there are reasons to remain cautiously hopeful. Lawsuits to challenge the funding cap are already in the works, according to BBC reporting, and court rulings could delay or soften the impact. Additionally, future administrations or congressional appropriations could reverse or adjust these policies.

In the meantime, both candidates and employers can take steps to maintain U.S. leadership in biomedical research. Institutions might shift toward more public-private partnerships; companies can support former academics with opportunities for continued professional development. Recruiters and HR professionals can proactively guide displaced researchers toward roles that align with their values and scientific passions.

Most importantly, the biomedical field must reinforce its value not just to the government, but to the public. Framing research as a driver of national security, economic competitiveness, and quality of life may help rally bipartisan support in future election cycles.

Ultimately, while the 15% cap poses serious concerns for the traditional structure of biomedical research, it could also catalyze a rebalancing of how – and where – scientific innovation happens. The private sector has an opportunity not only to absorb talent, but to help redefine the research landscape with an especial focus on resilient, agile, and forward-thinking.

In this “new normal,” strategic adaptability will be key. For now, the best course for both individuals and organizations is to remain informed, stay flexible, and work collaboratively across sectors to keep the lifeblood of biomedical innovation flowing strong.

Here at Sci.bio, we work with a variety of candidates from new graduates to experienced executives and have myriad open roles. We pride ourselves on connecting our highly discerning clients with candidates who fit their specific needs. Check out our job search page to see current openings and follow us on LinkedIn for more information.

Related Blogs:
Useful Online Courses to Beef Up your Resume
Biotech Recruiting into the Dark: Hiring in Uncertain Economic Times
Industrial Careers: Big Pharma vs. Biotech?

Resources:
1. Impact of Trump Administration Directives on Scientific Research in the U.S.
2. Trump administration to cut billions from biomedical research funding
3. The possible long-term impact of Trump’s cuts to medical research funding
4. Trump policies spark fears of brain drain, threatening to undermine U.S. dominance in biomedicine

Q1 2025 Upcoming FDA Decision Dates (PDUFAs)

Q1 2025 Upcoming FDA Decision Dates (PDUFAs)

As we settle into 2025, staying informed about the latest developments in the ever-evolving biotech industry remains crucial. With the shifts and approvals that shaped 2024, the early months of this year will set the stage for emerging trends and key advancements in the sector.

Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in Q1 2025 and how they may impact the industry moving forward.

 
PDUFA Date COMPANY NAME Orphan Drug Indication
01-02-25 Vertex Pharmaceuticals Inc. Vanza triple Cystic Fibrosis
01-03-25 OWP Pharmaceuticals SUBVENITE (lamotrigine) Epilepsy and bipolar disorder
01-07-25 Mesoblast Limited Ryoncil (remestemcel) Steroid-refractory acute graft versus host disease (SR-aGVHD)
01-15-25 Atara Biotherapeutics Tabelecleucel (Tab-cel) Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
01-17-25 AstraZeneca & Daiichi Sankyo Datopotamab Deruxtecan Unresectable or metastatic hormone receptor positive, HER2-negative breast cancer
01-17-25 Amgen Sotorasib (Lumakras) Chemorefractory metastatic colorectal cancer (CRC) with a KRAS G12C mutation.
01-25-25 Eisai & Biogen Leqembi Early Alzheimer’s disease
01-30-25 Vertex Pharmaceuticals Inc. JOURNAVX (suzetrigine) Moderate-to-Severe Acute Pain
01-30-25 Axsome Therapeutics, Inc. AXS-07 Acute Treatment of Migraine
02-01-25 Supernus Pharmaceuticals, Inc. SPN-830 Motor fluctuations in Parkinson’s disease
02-04-25 Merus Zenocutuzumab (Zeno) NRG1+ NSCLC and Pancreatic Cancer
02-07-25 Indivior Sublocade Moderate to severe opioid use disorder (OUD)
02-08-25 Otsuka and Lundbeck Brexpiprazole Adults with post-traumatic stress disorder (PTSD)
02-12-25 Astellas Pharma Inc. Izervay Geographic atrophy secondary to age-related macular degeneration
02-14-25 GSK 5-in-1 meningococcal ABCWY (MenABCWY) Invasive meningococcal disease
02-17-25 Deciphera Pharmaceuticals Vimseltinib Tenosynovial giant cell tumor (TGCT)
02-28-25 Eton Pharmaceuticals ET-400 Adrenocortical Insufficiency
02-28-25 Springworks Therapeutics Mirdametinib Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN)
03-06-25 scPharmaceuticals Furosemide (Furoscix) Edema due to fluid overload in patients with chronic kidney disease (CKD)
03-06-25 ARS Pharmaceuticals Neffy Type I allergic reactions, incl. anaphylaxis, in adults and children who weigh 15 to 30 kg
03-12-25 Organon & Co. VTAMA (tapinarof) Atopic dermatitis in adults and children two years of age and older
03-18-25 Neurotech Pharmaceuticals NT-501 Macular Telangiectasia Type 2 (MacTel)
03-20-25 Relay Therapeutics, Inc. Lirafugratinib Advanced or metastatic hepatocellular carcinoma
03-20-25 Elevar Therapeutics Rivoceranib/Camrelizumab Unresectable or metastatic hepatocellular carcinoma
03-23-25 Alnylam Pharmaceuticals Vutrisiran ATTR amyloidosis with cardiomyopathy (ATTR-CM)
03-24-25 Telix Pharmaceuticals Limited TLX007-CDx Prostate cancer
03-25-25 Theratechnologies Inc. Tesamorelin F8 Excess abdominal fat in adults with HIV and lipodystrophy
03-26-25 GSK Gepotidacin Urinary tract infections in female adults and adolescents
03-27-25 Soleno Therapeutics Diazoxide choline (DCCR) Prader-Willi syndrome
03-27-25 Milestone Pharmaceuticals CARDAMYST (etripamil) Paroxysmal supraventricular tachycardia (PSVT)
03-28-25 Sanofi & Alnylam Pharmaceuticals Fitusiran Hemophilia A or B
03-28-25 Mirum Pharmaceuticals Inc. Chenodiol Cerebrotendinous xanthomatosis
Q1 2025 AstraZeneca & Daiichi Sankyo Enhertu HER2-low or HER2-ultralow metastatic breast cancer
Using a Recruiter for Roles Outside of Your Industry

Using a Recruiter for Roles Outside of Your Industry

Author:  Tara Smylie

Ever find yourself staring at a job opening and thinking, “who is the right person to hire for this”? Anyone who’s ever been in a hiring role can relate. Sometimes, you may know the perfect fit right off the bat – but often, you’re left scratching your head. That’s where a recruiter can step in.

How Can a Recruiter Help?

Imagine having access to a network so vast that it’s more of a meta-network, composed of dozens of well-connected individuals and their wide professional webs: that’s what a recruiter brings to the table. A recruiter can tap into their extensive connections to expand your reach far beyond your LinkedIn contacts. Whether you’re in need of someone who’s mastered multiple software platforms or has hands-on lab experience, a recruiter specializing in filling science-based roles will know where to look.

Not to mention, recruiters are pros at assessing your business needs and finding someone who’s the best of both worlds. A recruiter doesn’t just look at the job description; they’ll analyze your company’s culture, goals, and pain points to find a candidate who ticks all the boxes. Plus, they help you figure out what kind of expertise you actually need. Sometimes, you might think you need a jack-of-all-trades, but what you really need is simply a master of one (or two).

The Trickiest Roles to Fill

Now, let’s dive into the kinds of roles that might leave you feeling out of your depth. Picture this: You need a communications professional, but your company specializes in biotech. You have no idea where to start. A recruiter can bridge that gap, finding someone who fits into your company despite their specialty in something else.

Need a medical writer who can also whip up scientific graphics? A recruiter can help you define exactly what you’re looking for and bring in someone who can handle multiple subject areas with ease.

Recruiters are seasoned pros at crossing industry lines and finding interdisciplinary talent. They can help you snag someone who brings a fresh perspective and a unique talent set to your team. It’s like getting the best of both worlds – someone with strong applicable skills who can also adapt to your industry’s specific needs.

Benefits of the Recruiter Route

Working with a recruiter is like having a secret weapon in your hiring arsenal. A recruiter can help you both expand your network and tap into the one you already have, forging connections you didn’t even know existed. They’ll work with you to sketch out your ideal candidate profile, ensuring you’re all on the same page from the get-go.

Sure, you could train someone from within your company to fill the role, but bringing in a well-suited outsider can offer a fresh perspective you might not have considered. A hire with outside experience will bring new ideas, new strategies, and new ways of thinking that can elevate your team to new heights.

The Takeaway

Recruiters aren’t just there to fill vacancies; they’re there to find the perfect match for roles that fall outside your company’s expertise. They’re your go-to for hiring highly specialized positions or interdisciplinary roles, and they’re equipped with the know-how to find someone who fits your organization like a glove.

If you’re looking to fill a role with a highly qualified candidate, Sci.bio’s recruitment services can help. We know that no two clients are the same, so we provide customized recruiting support that adapts to a given client’s structure and needs, and have placed successful candidates with a variety of companies. Please contact us to connect with a recruiter and discuss your needs, and follow us on LinkedIn to stay up to date.

Related Blogs:

Struggling To Fill A Job Vacancy?
The Collapse of Internal Talent Acquisition Functions – Challenges and Solutions
A Researcher, a Communicator, or Something in Between? Knowing Who to Hire for Each Role

References
1. https://www.sci.bio/struggling-to-fill-a-job-vacancy/
2. https://ca.indeed.com/career-advice/career-development/advantages-of-external-recruitment
3. https://www.linkedin.com/advice/0/how-do-you-recruit-difficult-to-fill-positions
Choosing Candidates That Align with Your Long-Term Goals

Choosing Candidates That Align with Your Long-Term Goals

Author:  Tara Smylie

Hiring the right candidates is far from a straightforward process. You’re not just filling a vacancy; you’re making a decision that could shape the future of your organization. While it might seem simple to choose the most qualified applicant, finding someone whose skills and aspirations align with both your short-term needs and your long-term vision is a delicate process.

Aligning Goals and Vision

It’s not necessarily about finding someone who will stay with you for twenty years, though that might be a bonus, but about identifying a candidate whose personal and professional aspirations complement your company’s objectives.

For instance, consider a candidate eager to develop skills in data analytics. If your company is leveraging big data to drive decisions, this individual’s goals align perfectly with your strategic direction. Their desire to grow in this area means they’re likely to be motivated, engaged, and invested in their role – and as long as they stay with you, they’ll be eager to develop these mutually beneficial skills.

Seeking Growth-Oriented Talent

Long-term alignment involves finding candidates who will help your company grow rather than stagnate. This means selecting individuals who understand the necessity of continuous improvement and see the value of improving what may already function “well enough”.

In the rapidly evolving world of life science and biotech, staying ahead of the curve is crucial. Fresh talent can bring new perspectives, and even spot inefficiencies or opportunities for innovation that existing employees might overlook. A candidate who is curious, adaptable, and proactive can be a catalyst for changes you’ve been seeking.

Tailoring Your Selection to Your Company’s Future

When selecting candidates, consider where your company is today and where it will be in the future. For example, if your company is experiencing rapid growth, you’ll need employees who are adaptable and willing to learn new skills. These individuals thrive in dynamic environments, handle multiple responsibilities, and are comfortable with change.

If your company plans to adopt a new strategy or pivot to a different business model, it’s crucial to find candidates who can adapt to different approaches. You need someone skilled in your current processes but open to implementing new strategies. This flexibility can be a significant asset as your company navigates tough transitions.

Aligning Skills with Present and Future Needs

A candidate’s skills must meet your company’s current needs while also aligning with your long-term goals. It’s a balancing act: you want someone who can contribute immediately while also being a good fit for the future.

Let’s say your company is expanding its digital marketing efforts. A candidate with a strong background in traditional marketing might bring valuable insights, but if they lack experience in digital channels, they might struggle to contribute to their fullest potential right away. However, if this candidate is enthusiastic about learning digital marketing and has demonstrated adaptability, they could still be a great long-term fit.

Practical Steps to Ensure Alignment

To identify candidates whose goals align with your long-term vision, consider these steps:

  1. Clearly Define Your Vision: Before you begin hiring, take inventory of your company’s long-term objectives. This helps identify the traits and skills most important in a candidate.
  2. Assess Alignment During Interviews: Ask candidates about their long-term goals and how they see themselves fitting into your company’s future. Look for signs that their aspirations complement your company goals.
  3. Prioritize Growth Potential: Don’t just look for candidates who meet your current needs; consider their potential to grow with your company. Are they adaptable? Do they have a track record of learning new skills? These qualities are crucial for long-term success.
  4. Consider Cultural Fit: Alignment isn’t just about skills and goals; it’s also about how well a candidate fits with your company culture. A good cultural fit enhances collaboration, productivity, and job satisfaction.

A Team to Stand the Test of Time

By focusing on alignment, you can build a team that not only meets today’s challenges but also drives forward your company’s long-term goals.

If you’re looking to fill a role with a highly qualified candidate, Sci.bio’s recruitment services can help. We know that no two clients are the same, so we provide customized recruiting support that adapts to a given client’s structure and needs and have placed successful candidates with a variety of companies. Please contact us to connect with a recruiter and discuss your needs and follow us on LinkedIn to stay up to date.

Related Blogs:

Hiring with Corporate Culture in Mind
Want Good Hires Who Stick Around? Make Their Careers Your Business
Hiring the Right Person

Resources:
5 Qualities of a Good Employee and Candidate and How to Evaluate Them in an Interview
Selection Process: 7 Steps & Best Practices To Hire Top Talent

Q4 2024 Upcoming FDA Decision Dates (PDUFAs)

Q4 2024 Upcoming FDA Decision Dates (PDUFAs)

As we head into a busy holiday season and look towards 2025, it’s important to stay up-to-date on the news in the ever-evolving biotech industry. During a year of transition such as 2024, the remaining FDA approval dates this year have the potential to solidify trends and shape the outlook for the industry in 2025.

Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in the remainder of 2024.

 
DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
10-04-2024 Biofrontera Ameluz Actinic keratosis (AK)
10-08-2024 Bristol Myers Squibb Neoadjuvant nivolumab (Opdivo) IIA to IIIB non–small cell lung cancer (NSCLC)
10-08-2024 Zealand Pharma Dasiglucagon Hypoglycemia in Congenital Hyperinsulinism
10-11-2024 Pfizer Hympavzi (marstacimab-hncq) Hemophilia A or B without inhibitors
10-15-2024 Intercept Pharmaceuticals Ocaliva (obeticholic acid) Primary biliary cholangitis (PBC)
10-17-2024 Avadel Pharmaceuticals Lumryz (sodium oxybate) Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
10-21-2024 Camurus Oclaiz (CAM2029) Acromegaly
10-25-2024 Iterum Therapeutics ORLYNVAH™ (Oral Sulopenem) Uncomplicated Urinary Tract Infections
10-29-2024 Novartis Asciminib (Scemblix) Chronic myeloid leukemia
11-4-2024 Journey Medical Corporation DFD-29 (minocycline hydrochloride) Inflammatory lesions and erythema of rosacea
11-13-2024 PTC Therapeutics Upstaza (eladocagene exuparvovec) Aromatic L–amino Acid Decarboxylase (AADC) deficiency
11-16-2024 Autolus Therapeutics Obecabtagene autoleucel (obe-cel) Relapsed/refractory adult B-cell acute lymphoblastic leukemia (ALL)
11-27-2024 Roche Inavolisib HR+/HER2– PIK3CA+ Breast Cancer
11-28-2024 Applied Therapeutics Inc. Govorestat (AT-007) Galactosemia type 1
11-29-2024 Zymeworks & Jazz Pharmaceuticals Zanidatamab HER2-Positive Metastatic Biliary Tract Cancer
11-29-2024 BridgeBio Pharma Acoramidis Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
11-30-2024 Shorla Oncology SH-201 Leukemia and other cancers.
12-19-2024 Ionis Pharmaceuticals Olezarsen Familial chylomicronemia syndrome
12-20-2024 Lexicon Pharmaceutical Zynquista (sotagliflozin) Type 1 Diabetes and chronic kidney disease
12-26-2024 Rhythm Pharmaceuticals Imcivree (setmelanotide) Bardet-Biedl syndrome or POMC/LEPR deficiency
12-26-2024 Syndax Pharma Revumenib Relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia
12-27-2024 Soleno Therapuetics DCCR (Diazoxide Choline) Prader-Willi Syndrome (PWS)
12-28-2024 Checkpoint Therapeutics Cosibelimab Advanced Cutaneous Squamous Cell Carcinoma
12-28-2024 Xcovery Holdings Ensartinib Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
12-29-2024 Halozyme Therapeutics & Bristol Myers Squibb Opdivo (nivolumab) Advanced or Metastatic Solid Tumors
12-30-2024 Neurocrine Biosciences Crinecerfont Congenital adrenal hyperplasia (CAH)
Dec 2024 BeiGene Tevimbra (tislelizumab) Unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
Q4 2024 AstraZeneca Tagrisso (osimertinib) Stage III EGFR-mutated lung cancer