Axsome Therapeutics (NASDAQ: AXSM), and Summit Therapeutics (NASDAQ: SMMT). (Alnylam Pharmaceuticals): In her comments ...

The US FDA issued a warning on Saturday that some popular allergy medications could cause a rare but severe itching side ...

Roche RHHBY announced today that the FDA has approved a label expansion of ophthalmology drug Susvimo (ranibizumab injection). The regulatory body approved the drug Susvimo for the treatment of ...

FDA warns of severe itching risk when stopping long-term use of allergy medications cetirizine and levocetirizine, affecting ...

Mepolizumab has had a bumpy road to arriving at its indication in COPD. An FDA advisory committee in 2018 declined to ...

The FDA has cleared Brainstorm to initiate a Phase 3b clinical trial testing NurOwn (debamestrocel) in people with moderate ...

The FDA has approved Emrelis for the treatment of adult patients with locally advanced or metastatic NSCLC with high c-Met protein overexpression.

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

The vaccine is expected to remain available for anyone who is at least 65 or who has a medical condition, leaving many ...

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...