2024 FDA Drug Approvals: Small Companies Make Significant Impact
Small Companies' Impact:
Small biotech companies played a crucial role in 2024 FDA drug approvals, securing several key nods for innovative treatments34.
Total Approvals:
The FDA approved 50 new drugs and 11 biologics in 2024, highlighting a productive year for pharmaceutical innovation3.
Notable Approvals:
Bristol Myers Squibb’s Cobenfy:
The first novel therapeutic for schizophrenia in 35 years2.
Eli Lilly’s Kisunla:
Approved for Alzheimer’s disease2.
Madrigal Pharmaceuticals’ Rezdiffra:
The first-ever treatment for metabolic dysfunction-associated steatohepatitis (MASH)2.
AstraZeneca’s Imfinzi:
Expanded label for limited-stage small cell lung cancer2.
Merus’ Bizengri:
Accelerated approval for pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC)2.
Orphan Drug Approvals:
Several orphan drugs were approved, including treatments for Duchenne muscular dystrophy, pulmonary arterial hypertension, and transfusion-dependent beta thalassemia1.
Biosimilars:
Biocon Biologics’ Yesintek, a biosimilar to Johnson & Johnson’s Stelara, was approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis2.
Regulatory Updates:
The FDA issued Complete Response Letters to some companies, including Zealand Pharma for glepaglutide, highlighting the need for additional clinical data2.
Market Impact:
Small companies' success in securing FDA approvals underscores their growing influence in the pharmaceutical industry, potentially shifting market dynamics34.
Sources:
1. https://checkrare.com/2024-orphan-drugs-pdufa-dates-and-fda-approvals-2/
2. https://www.biospace.com/biospace-fda-decision-tracker
3. https://www.raps.org/news-and-articles/news-articles/2025/1/recon-drugmakers-ring-in-2025-with-new-round-of-pr