When you work in an industry as rapidly changing as biotechnology, it’s crucial to stay up to date. Awareness of the FDA’s new drug approval dates is especially crucial: the decisions put forth on these dates can significantly affect the outlook of the companies involved, and these ramifications often reverberate through the industry as a whole.

Read on for a rundown of the FDA’s upcoming decision dates for new drug approvals in the first quarter of 2024.

 

DATE

COMPANY NAME

DRUG NAME

USE/THERAPEUTIC AREA

01/20/2024

Merck

Keytruda (pembrolizumab)

Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

01/22/2024

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)

1/26/2024

Defender Pharmaceuticals

scopolamine (DPI-386)

Motion Sickness

1/31/2024

Sanofi and Regeneron

Dupixent (dupilumab)

Eosinophilic esophagitis (EoE)

1/31/2024

Vyluma

NVK002

Myopia

2/13/2024

Ipsen

Onivyde (irinotecan liposome injection)

Metastatic pancreatic ductal adenocarcinoma

2/22/2024

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

3/4/2024

Eyenovia

APP13007

Post-operative inflammation and pain following ocular surgery

3/4/2024

Vanda Pharmaceuticals

HETLIOZ (tasimelteon)

Non-24-Hour Sleep-Wake Disorder (Non-24) in adults

03/08/2024

Viatris and Mapi Pharma

Copaxone (Glatiramer Acetate Depot)

Relapsed forms of multiple sclerosis (MS)

3/13/2024

Mirum Pharmaceuticals

Livmarli (maralixibat)

Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)

3/14/2024

Madrigal Pharmaceuticals

Resmetirom

Nonalcoholic steatohepatitis (NASH)

3/14/2024

Bristol Myers Squibb

Breyanzi (lisocabtagene maraleucel)

Relapsed/refractory large B-cell lymphoma (LBCL)

3/16/2024

Optinose

XHANCE

Chronic rhinosinusitis with nasal polyps (CRSwNP)

3/18/2024

Orchard Therapeutics

OTL-200

Metachromatic leukodystrophy (MLD)

3/21/2024

Italfarmaco Group

Givinostat

Duchenne Muscular Dystrophy (DMD)

3/23/2024

Incyte

ruxolitinib

myelofibrosis, polycythemia vera, and graft vs. host disease (GVHD)

3/26/2024

Merck

Sotatercept

Pulmonary arterial hypertension (PAH)

3/27/2024

Akebia Therapeutics

Vadadustat

Anemia in patients with CKD undergoing dialysis

3/27/2024

Esperion

NEXLETOL (bempedoic acid)

Lowers the level of cholesterol in the blood

3/30/2024

Vertex and CRISPR Therapeutics

Casgevy (exagamglogene autotemcel)

Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

3/31/2024

Rocket Pharmaceuticals

RP-L201 (marnetegragene autotemcel)

Leukocyte adhesion deficiency-I (LAD-I)

3/31/2024

Regeneron Pharmaceuticals

Odronextamab (REGN1979)

Relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL)