Browsing Tag
US Food and Drug Administration
333 posts
Dr. Reddy’s (NSE: DRREDDY) signals dual-track U.S. growth strategy with abatacept biosimilar BLA acceptance and OTC eye-care expansion
Discover how Dr. Reddy’s FDA-accepted abatacept biosimilar and OTC eye-care launch are reshaping its U.S. growth and investor outlook.
Organon (NYSE: OGN) secures FDA approval for five-year use of NEXPLANON contraceptive implant, adding new REMS training requirement
Find out how Organon’s NEXPLANON just got FDA approval for five-year use—and what the new REMS program means for doctors and competitors.
Regulatory breakthrough: What the MHRA–FDA tie-up means for medtech approvals
Find out how the MHRA–FDA collaboration is reshaping medical device regulation, AI safety, and faster patient access across the UK and US healthcare systems.
Alembic Pharmaceuticals gains three USFDA approvals in oncology and neurology, but can these launches offset U.S. pricing pressures?
Alembic Pharmaceuticals secures USFDA approvals in oncology and neurology, but can these launches drive U.S. revenue growth? Read the full analysis.
GSK secures FDA approval for 5-in-1 meningococcal vaccine to expand protection for adolescents
GSK has received approval from the US Food and Drug Administration (FDA) for PENMENVY, a 5-in-1 meningococcal vaccine…
Biodexa Pharmaceuticals gains FDA fast track designation for eRapa, paving way for new colorectal cancer prevention strategies
Biodexa Pharmaceuticals witnessed a sharp surge in its American depositary receipts (ADRs), rising 75% to $7.13 during Monday…
Neuren Pharmaceuticals advances NNZ-2591 for Phelan-McDermid syndrome to Phase 3 clinical trial
Neuren Pharmaceuticals has secured approval from the United States Food and Drug Administration (FDA) to progress into the…
Primary IgA nephropathy : FDA grants full approval to Travere Therapeutics’ Filspari
In a groundbreaking move, the US Food and Drug Administration (FDA) has granted full approval to Travere Therapeutics’…
Granules India faces six observations after US FDA inspection at Gagillapur facility in Hyderabad
Granules India Limited has recently completed a US Food and Drug Administration (US FDA) inspection at its Gagillapur…
FDA approval for Zurnai Auto-Injector: A new weapon in the fight against opioid overdose
In a major development in the battle against the opioid epidemic, Purdue Pharma’s Zurnai Auto-Injector has been granted…