Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline

Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics

FDA presses 2,200+ companies to fix missing clinical trial results

Move amid evidence of widespread reporting gaps

GE HealthCare and Medtronic launch real-time brain surgery imaging integration

The Stealth AXiS surgical navigation system was recently cleared by the US Food and Drug Administration (FDA) for cranial procedures in the United States

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million

ImmunityBio responds to FDA concerns over promotional content

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.

FDA okays Eli Lilly’s new weight-loss pill, expanding options for millions

The approval is backed by results from Lilly’s ATTAIN clinical trial program, which showed significant weight loss among participants

Biogen bags FDA nod for high dose SPINRAZA in spinal muscular atrophy

The new regimen, delivering 50 mg/5 mL and 28 mg/5 mL doses, offers a higher concentration of the drug for both loading and maintenance phases

FDA nod to Johnson & Johnson’s oral psoriasis therapy 'ICOTYDE'

New targeted pill offers hope for adults and teens with moderate-to-severe plaque psoriasis