DATE |
COMPANY NAME |
DRUG NAME |
USE/THERAPEUTIC AREA |
01/3/2024 |
Checkpoint Therapeutics |
Cosibelimab |
Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma |
01/5/2024 |
Novan |
Berdazimer Gel, 10.3% |
Molluscum Contagiosum |
01/12/2024 |
Astellas |
Olbetuximab |
Gastroesophageal junction (GEJ) adenocarcinoma |
01/12/2024 |
Astellas Pharma |
Zolbetuximab |
Gastric Cancer |
01/13/2024 |
GC Biopharma |
GC5107B |
Primary Humoral Immunodeficiency (PI) |
01/17/2024 |
Merck |
WELIREG (belzutifan) |
Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) |
01/20/2024 |
Merck |
Keytruda (pembrolizumab) |
Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma |
01/20/2024 |
Theratechnologies |
Tesamorelin F8 Formulation |
Reduction of excess abdominal fat in adults with HIV who have lipodystrophy |
01/23/2024 |
Heron Therapeutics |
ZYNRELEF (bupivacaine and meloxicam) |
Post-Operative Pain |
01/24/2024 |
Liquidia Corporation |
Yutrepia (treprostinil) |
Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) |
01/26/2024 |
Defender Pharmaceuticals |
scopolamine (DPI-386) |
Motion Sickness |
01/31/2024 |
Sanofi and Regeneron |
Dupixent (dupilumab) |
Eosinophilic esophagitis (EoE) |
01/31/2024 |
Vyluma |
NVK002 |
Myopia |
02/13/2024 |
Ipsen |
Onivyde (irinotecan liposome injection) |
Metastatic pancreatic ductal adenocarcinoma |
02/22/2024 |
Venatorx Pharmaceuticals |
cefepime-taniborbactam |
Complicated Urinary Tract Infections (cUTI), including Pyelonephritis |
02/24/2024 |
Iovance Biotherapeutics |
Lifileucel |
Advanced Melanoma |
02/24/2024 |
Alvotech |
AVT02 |
Inflammatory diseases including rheumatoid arthritis |
02/26/2024 |
Minerva Neurosciences |
Roluperidone |
Schizophrenia- Negative Symptoms |
03/4/2024 |
Eyenovia |
APP13007 |
Post-operative inflammation and pain following ocular surgery |
03/4/2024 |
Vanda Pharmaceuticals |
HETLIOZ (tasimelteon) |
Non-24-Hour Sleep-Wake Disorder (Non-24) in adults |
03/8/2024 |
Viatris and Mapi Pharma |
Copaxone (Glatiramer Acetate Depot) |
Relapsed forms of multiple sclerosis (MS) |
03/13/2024 |
Mirum Pharmaceuticals |
Livmarli (maralixibat) |
Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) |
03/14/2024 |
Madrigal Pharmaceuticals |
Resmetirom |
Nonalcoholic steatohepatitis (NASH) |
03/14/2024 |
Bristol Myers Squibb |
Breyanzi (lisocabtagene maraleucel) |
Relapsed/refractory large B-cell lymphoma (LBCL) |
03/16/2024 |
Optinose |
XHANCE |
Chronic rhinosinusitis with nasal polyps (CRSwNP) |
03/18/2024 |
Orchard Therapeutics |
OTL-200 |
Metachromatic leukodystrophy (MLD) |
03/21/2024 |
Italfarmaco Group |
Givinostat |
Duchenne Muscular Dystrophy (DMD) |
03/23/2024 |
Incyte |
ruxolitinib |
myelofibrosis, polycythemia vera, and graft vs. host disease (GVHD) |
03/26/2024 |
Merck |
Sotatercept |
Pulmonary arterial hypertension (PAH) |
03/27/2024 |
Akebia Therapeutics |
Vadadustat |
Anemia in patients with CKD undergoing dialysis |
03/27/2024 |
Esperion |
NEXLETOL (bempedoic acid) |
Lowers the level of cholesterol in the blood |
03/30/2024 |
Vertex and CRISPR Therapeutics |
Casgevy (exagamglogene autotemcel) |
Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia |
03/31/2024 |
Rocket Pharmaceuticals |
RP-L201 (marnetegragene autotemcel) |
Leukocyte adhesion deficiency-I (LAD-I) |
03/31/2024 |
Regeneron Pharmaceuticals |
Odronextamab (REGN1979) |
Relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL) |
04/01/2024 |
AstraZeneca |
Voydeya (danicopan) |
Extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH) |
04/02/2024 |
Vanda Pharmaceuticals |
Fanapt |
Manic or mixed episodes associated with bipolar I disorder in adults |
04/03/2024 |
Basilea Pharmaceutica AG |
ZEVTERA (Ceftobiprole) |
SAB infections and ABSSSI in adults and for CABP in adults and pediatric patients |
04/04/2024 |
Bristol Myers Squibb & 2seventy Bio |
Abecma (idecabtagene vicleucel; ide-cel) |
Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy |
04/05/2024 |
Janssen & Legend Biotech |
Carvykti (ciltacabtagene autoleucel; cilta-cel) |
Relapsed or refractory multiple myeloma |
04/05/2024 |
Bristol Myers Squibb |
Opdivo (nivolumab) |
Unresectable or metastatic urothelial carcinoma |
04/05/2024 |
Supernus Pharmaceuticals |
SPN-830 |
Motor fluctuations (OFF episodes) in Parkinson’s disease |
04/05/2024 |
AbbVie/Immunogen |
ELAHERE |
Platinum-Resistant Ovarian Cancer |
04/23/2024 |
ImmunityBio |
N-803 |
BCG-unresponsive non-muscle invasive bladder carcinoma (NMIBC) |
04/28/2024 |
Aquestive Therapeutics |
Libervant (diazepam) Buccal Film |
Seizure clusters in patients between two and five years of age |
04/29/2024 |
PharmaTher |
KETARX (Ketamine) |
Mental health, neurological and pain disorders |
04/30/2024 |
Day One Biopharmaceuticals |
Tovorafenib |
Relapsed or progressive pediatric low-grade glioma (pLGG) |
04/30/2024 |
X4 Pharmaceuticals |
Mavorixafor |
WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome |
04/30/2024 |
Neurocrine Biosciences Inc |
INGREZZA (valbenazine) |
Tardive dyskinesia and chorea associated with Huntington’s disease |
05/09/2024 |
Astellas Pharma Inc. |
PADCEV (enfortumab vedotin-ejfv) |
Advanced Bladder Cancer |
05/09/2024 |
Merck |
KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) |
Locally advanced or metastatic urothelia |
05/09/2024 |
Pfizer & GENMAB |
Tivdak |
Recurrent or Metastatic Cervical Cancer |
05/13/2024 |
Dynavax Technologies Corp |
HEPLISAV-B |
Infection caused by all known subtypes of hepatitis B virus |
05/14/2024 |
Ascendis Pharma |
TransCon PTH (Palopegteriparatide) |
Hypoparathyroidism |
05/23/2024 |
Bristol Myers Squibb |
Breyanzi (lisocabtagene maraleucel) |
Relapsed or refractory follicular lymphoma (FL) |
05/25/2024 |
Abeona Therapeutics |
Pz-cel |
Recessive dystrophic epidermolysis bullosa |
05/30/2024 |
Daiichi Sankyo & AstraZeneca |
Enhertu (trastuzumab deruxtecan) |
Unresectable or Metastatic HER2 Positive Solid Tumors |
05/31/2024 |
Bristol Myers Squibb |
Breyanzi (lisocabtagene maraleucel) |
Relapsed or refractory mantle cell lymphoma (MCL) |
06/04/2024 |
Catalyst Pharmaceutical |
Firdapse (amifampridine) |
Lambert-Eaton myasthenic syndrome (“LEMS”) |
06/07/2024 |
GSK |
AREXVY (RSV Vaccine) |
Prevention of RSV disease in adults aged 50-59 at increased risk |
06/10/2024 |
Ipsen and GENFIT |
Elafibranor |
Rare cholestatic liver disease, primary biliary cholangitis (PBC) |
06/12/2024 |
Amgen |
Tarlatamab |
Advanced small cell lung cancer (SCLC) |
06/15/2024 |
Bristol-Myers Squibb |
Augtyro (repotrectinib) |
NTRK-Positive Locally Advanced or Metastatic Solid Tumors |
06/16/2024 |
Geron Corporation |
Imetelstat |
Lower risk myelodysplastic syndromes (MDS) |
06/17/2024 |
Merck & Ligand Pharmaceuticals |
V116 |
Prevent of invasive pneumococcal disease and pneumococcal pneumonia |
06/21/2024 |
Sarepta Therapeutics |
ELEVIDYS (delandistrogene moxeparvovec-rokl) |
Duchenne muscular dystrophy (DMD) |
06/21/2024 |
Argenx |
VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) |
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
06/21/2024 |
Merck & Co Inc. |
KEYTRUDA (pembrolizumab) |
Advanced endometrial cancer |
06/21/2024 |
Bristol-Myers Squibb |
KRAZATI (adagrasib) |
KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) |
06/21/2024 |
Harmony Biosciences |
WAKIX (pitolisant) |
Excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy |
06/26/2024 |
Merck & Daiichi Sankyo |
Patritumab deruxtecan (HER3-DXd) |
Locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies |
06/26/2024 |
Verona Pharma plc |
Ensifentrine |
Asthma and chronic obstructive pulmonary disease (COPD) |
06/27/2024 |
Sanofi |
Dupixent (dupilumab) |
Chronic obstructive pulmonary disease (COPD) with type 2 inflammation |
06/28/2024 |
AbbVie & GENMAB |
EPKINLY (Epcoritamab-bysp) |
Elapsed or Refractory Follicular Lymphoma (FL) |
06/30/2024 |
Rocket Pharmaceuticals |
RP-L201 (marnetegragene autotemcel) |
Leukocyte adhesion deficiency-I (LAD-I) |
07/7/2024 |
Arcutis Biotherapeutics Inc. |
Roflumilast Cream 0.15% |
Atopic Dermatitis in Adults and Children Down to Age 6 |
07/15/2024 |
Orexo AB |
OX124 |
opioid overdose |
07/19/2024 |
Phathom Pharmaceuticals Inc |
VOQUEZNA (vonoprazan) Tablets |
Heartburn associated with Non-Erosive GERD |
07/25/2024 |
AstraZeneca |
IMFINZI |
Resectable non-small cell lung cancer |
07/27/2024 |
Alpha Cognition Inc. |
ALPHA-1062 |
Mild-to-moderate Alzheimer’s disease in U.S. |
07/31/2024 |
Xspray Pharma |
Dasynoc (dasatinib amorphous) |
Chronic myeloid leukemia (CML) |
08/4/2024 |
Adaptimmune Therapeutics |
Afami-cel |
Advanced synovial sarcoma |
08/10/2024 |
Humacyte, Inc. |
Human Acellular Vessel |
Vascular trauma |
08/13/2024 |
Citius Pharmaceuticals |
LYMPHIR (denileukin diftitox) |
Relapsed or refractory cutaneous T-cell lymphoma (CTCL) |
08/14/2024 |
Ascendis Pharma |
TransCon PTH (palopegteriparatide) |
Hypoparathyroidism |
08/14/2024 |
Gilead Sciences |
Seladelpar |
Primary Biliary Cholangitis (PBC) |
08/20/2024 |
Royal Pharma |
vorasidenib |
IDH-mutant glioma |
08/22/2024 |
Regeneron Pharmaceuticals |
Linvoseltamab |
Relapsed/refractory (R/R) multiple myeloma (MM) |
08/23/2024 |
GSK |
Jemperli (dostarlimab) |
Primary advanced or recurrent endometrial cancer |
08/28/2024 |
Incyte Corporation / Syndax Pharmaceuticals |
Axatilimab |
Chronic Graft-Versus-Host Disease |
09/5/2024 |
Travere Therapeutics / Ligand Pharmaceuticals |
Filspari (sparsentan) |
IgA Nephropathy |
09/7/2024 |
AVADEL PHARMACEUTICALS |
LUMRYZ |
Cataplexy or EDS in the pediatric narcolepsy population |
09/18/2024 |
VANDA PHARMACEUTICALS |
Tradipitant |
Gastroparesis |
09/21/2024 |
Zevra Therapeutics / XOMA Corporation |
Arimoclomol |
Niemann-Pick disease type C |
09/23/2024 |
Heron Therapeutics |
ZYNRELEF |
Instillation to produce postsurgical analgesia for up to 72 hours after soft tissue and orthopedic procedures |
09/24/2024 |
IntraBio |
IB1001 (N-acetyl-L-leucine) |
Niemann-Pick disease Type C (NPC) |
09/25/2024 |
Merck |
KEYTRUDA (pembrolizumab) |
Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma |
09/26/2024 |
Syndax Pharmaceuticals |
Revumenib |
Relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia |
09/26/2024 |
Bristol-Myers Squibb |
KarXT |
Schizophrenia in adults |
09/27/2024 |
Regeneron Pharmaceuticals / Sanofi |
Dupixent |
Chronic obstructive pulmonary disease (COPD) with type 2 inflammation |
09/27/2024 |
Sanofi |
Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone |
treatment of transplant-ineligible newly diagnosed multiple myeloma |
Q2 2024 |
Pfizer |
Fidanacogene elaparvovec |
Hemophilia B |
Q2 2024 |
BeiGene |
Beukina (zanubrutinib) |
Relapsed or refractory follicular lymphoma |
Q2 2024 |
Roche |
XOLAIR (omalizumab) |
Asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU) |
Q2 2024 |
AstraZeneca |
TAGRISSO (osimertinib) |
Non-small cell lung cancer (NSCLC) |
Q2 2024 |
AstraZeneca |
FluMist Quadrivalent |
Active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. |