fda-and-biotech News
Alumis Insiders Signal Confidence with $6.2M Stock Purchase
Major shareholders increase their stake as the biotech company advances its pivotal drug trials for autoimmune diseases, signaling strong conviction ahead of key data releases.
Nuvalent CFO Acquires $1M in Shares After Cancer Drug Trial Fuels Stock Surge
The transaction follows positive pivotal data from the company's ALKOVE-1 lung cancer study, signaling strong insider confidence as shares trade near 52-week highs.
Regeneron Wins Key FDA Approval for Eylea HD in Retinal Disease
The expanded approval for treating Retinal Vein Occlusion allows for less frequent dosing, sharpening its competitive edge against Roche's Vabysmo.
Telix Pharma Stock Hits 52-Week Low on FDA Rejection, SEC Probe
Shares tumble as the biopharmaceutical company faces a securities class-action lawsuit tied to manufacturing woes and an ongoing federal investigation.
Gilead Faces Long-Term HIV Threat as Merck's Rival Drug Succeeds in Trial
Merck's two-drug regimen proves as effective as Gilead's blockbuster Biktarvy, signaling a significant competitive shift in the multi-billion-dollar HIV market post-2026.
Merck Challenges Gilead's HIV Dominance with Positive Drug Trial
Investigational two-drug regimen proves non-inferior to Gilead's blockbuster Biktarvy in pivotal Phase 3 study, setting the stage for a new competitor in the lucrative HIV market.
Merck Shares Climb on European Approval of Subcutaneous Keytruda
New under-the-skin formulation of the blockbuster cancer drug aims to enhance patient convenience and defend market share ahead of patent expirations.
Celcuity Submits Breast Cancer Drug to FDA After 1,000% Stock Rally
Company's lead drug, Gedatolisib, moves to regulatory review for treating advanced HR+/HER2- breast cancer, a multi-billion dollar market.