fda-and-biotech News
Protara Therapeutics Moves to Raise Capital After Positive Cancer Drug Data
Company announces proposed public stock offering just a day after revealing promising interim results for its lead bladder cancer treatment, TARA-002.
Praxis Surges After Epilepsy Drug Trial Halted for Efficacy
A second positive FDA update for another key drug on the same day propelled shares higher, signaling strong momentum in the biotech's late-stage pipeline.
Capricor Shares Fall 15% on Stock Sale, Eclipsing Drug Trial Win
The move to raise capital comes just one day after the company announced positive Phase 3 results for its Duchenne muscular dystrophy therapy, Deramiocel.
Merck's Keytruda Launch Halted in Germany After Patent Injunction
Court ruling in favor of Halozyme disrupts rollout of a subcutaneous formulation key to defending the blockbuster cancer drug from biosimilar threats.
Halozyme Wins Injunction Against Merck's Keytruda SC in Germany
Court ruling halts German launch of the subcutaneous version of Merck's blockbuster cancer drug, setting the stage for high-stakes patent negotiations.
Medtronic Shares Rise on FDA Clearance for Hugo Surgical Robot
The medical device giant's entry into the U.S. robotic urology market sets up a direct challenge to Intuitive Surgical's long-standing dominance.
uniQure Shares Plunge After FDA Setback for Huntington's Drug
Regulator deems current data for gene therapy AMT-130 insufficient for a license application, prompting a wave of analyst price target cuts and delaying a key pipeline asset.
Denali Therapeutics Surges on $275M Royalty Deal for Brain Disease Drug
Shares jumped over 6% after the biotech firm secured funding from Royalty Pharma for its promising Hunter syndrome therapy, de-risking development ahead of a key FDA decision.