In a press release issued after market hours on February 20, Cipla announced that it has received approval for Nilotinib ...

Chimerix holds the potential to have the first approval of dordaviprone for treating recurrent H3 K27M mutant high-grade ...

Eli Lilly’s (LLY) new weight loss pill is still in clinical trials and has not yet been approved by regulators. But that hasn ...

BioMarin's gene therapy pipeline has had setbacks, including a three-year delay in US approval of Roctavian and stalled development of PKU gene therapy BMN 307 as the Food and Drug Administration ...

BridgeBio's launch of Attruby in the U.S. is off to a strong start. Read how this successful effort puts the biotech in a ...

Imagine a non-invasive, low-risk and cutting-edge therapy that can protect the vision of older adults. For the millions of ...

The FDA has approved a generic version of lenalidomide, a drug used to treat multiple myeloma and myelodysplastic syndromes, with availability set for Jan. 31, 2026.

The closing of the business combination with PowerUp Acquisition Corp. creates Nasdaq-listed biopharmaceutical company dedicated to developing breakthrough innovations in FDA approved drugs, ...

Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...

The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog, to improve glycemic control in patients with diabetes mellitus.

Developed by the Serum Institute of India, the rBCG product, which has been modified to improve its immunogenicity and safety, was evaluated in phase 1/2 clinical trials in Europe in patients with ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...