fda-and-biotech News
Vertex Dips Despite Positive Gene Therapy Data for Children
Shares edge lower as investors weigh strong clinical results for Casgevy in younger patients against the complex realities of its commercial rollout.
Scholar Rock Surges 50% as Muscular Atrophy Drug Nears FDA Review
A pivotal FDA meeting for its lead drug candidate and a multi-million dollar insider purchase have propelled the biotech's shares to near 52-week highs.
Adaptive Bio Plunges 13% as Natera Deal Fuels Oncology Test Rivalry
Natera's acquisition of Foresight Diagnostics for up to $450 million intensifies competition in the lucrative minimal residual disease (MRD) market.
Denali Therapeutics Slips After FDA Halts Pompe Disease Trial
The U.S. Food and Drug Administration placed a clinical hold on the company's Investigational New Drug application for DNL132, citing protocol concerns.
Abbott Shares Dip After FDA Warning on Glucose Monitors
The alert links certain FreeStyle Libre 3 sensors to over 700 serious injuries and 7 deaths globally, prompting a recall of 3 million devices in the U.S.
Praxis Shares Rise on FDA Path for Essential Tremor Drug
The company announced a successful pre-New Drug Application meeting with regulators for its novel treatment, ulixacaltamide, targeting a multi-billion dollar market.
Bristol Myers Squibb Gains on Expanded FDA Approval for Breyanzi
The CAR-T cell therapy becomes the first of its kind approved for Marginal Zone Lymphoma, bolstering the drugmaker's oncology pipeline amid patent concerns.
Vanda Pharma Shares Jump as FDA Lifts Hold on Motion Sickness Drug
The decision removes a key hurdle for tradipitant, positioning it to potentially become the first new treatment for motion sickness in over four decades.