Former FDA commissioner Scott Gottlieb came out against president-elect Trump’s choice of Robert F. Kennedy Jr. to lead the ...

The FDA is defending its increased use of non-binding guidance documents rather than legally-enforceable rulemakings, arguing ...

Johnson & Johnson has filed for two new pediatric indications as it looks to position its blockbuster immunotherapy Tremfya ...

Sanofi has made its single largest investment in China to date by pouring roughly €1 billion ($1.05 billion) into a new ...

Biocon Biologics scored an FDA approval for its Stelara biosimilar, marketed as Yesintek, the company announced Monday.

Novocure announced Monday morning that its electrical field wearable device combined with chemotherapy passed a late-stage ...

Olema Oncology and Novartis partner for Phase 3 trial combining palazestrant with Kisqali for breast cancer treatment. Olema ...

Agenus Bio is launching a CDMO arm using facilities in Berkeley and Emeryville, CA, while cutting spending to $100M by 2025.

Novartis is returning to Huntington's disease with a $1 billion upfront bet, plus another $1.9 billion in biobucks, for ...

Apogee Therapeutics plans to challenge Sanofi and Regeneron's Dupixent with its lead drug APG777, an IL-13 targeting ...

Merus reported updated Phase 2 trial results for petosemtamab in head and neck cancer, showing 40.4% overall response rate ...

FDA accepts Satsuma Pharmaceuticals' NDA resubmission for STS101 migraine drug. Hovione expands facilities in Ireland and New ...