Cipla shares in focus after U.S. FDA nod for Leukemia drug
In a press release issued after market hours on February 20, Cipla announced that it has received approval for Nilotinib ...
Chimerix: Potential 'First' In Targeting Recurrent High-Grade Glioma Patients
Chimerix holds the potential to have the first approval of dordaviprone for treating recurrent H3 K27M mutant high-grade ...
Eli Lilly (LLY) Stockpiles Weight Loss Pill Ahead of Regulatory Approval
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 Narrow Moat Supported by Rare Disease Therapies and Developing Pipeline
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 ...
JD Supra10h
FDA Approved Journavx, a Non-Opioid Drug for Pain Management
On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid ...
BridgeBio: Strong Start For Attruby
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 ...
Becker's Hospital Review13h
FDA approves generic cancer treatment for 2026 availability
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.
FDA approves first rapid-acting insulin biosimilar for patients with diabetes
Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...
Endocrinology Advisor1d
FDA Approves Merilog, a Rapid-Acting Insulin Biosimilar Product
The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog, to improve glycemic control in patients with diabetes mellitus.
Monthly Prescribing Reference1d
FDA Allows Use of Recombinant BCG Through Expanded Access Program
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 ...
infectiousdiseaseadvisor.com1d
FDA Drug Approval Decisions Expected in March 2025
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 ...
Harmony Biosciences: FDA Turns Away Idiopathic Hypersomnia Application
Harmony Biosciences Holdings said the Food and Drug Administration has turned away its application seeking expanded approval of its Wakix narcolepsy drug for the treatment of excessive daytime ...