fda-and-biotech News

Inspire Medical Surges 31% on Major Medicare Reimbursement Hike
FDA & Biotech
2mo ago

Inspire Medical Surges 31% on Major Medicare Reimbursement Hike

The sleep apnea device maker's shares soared after regulators finalized a payment increase of roughly 50%, prompting multiple analyst upgrades.

Capricor Stock Plummets 22% After Martin Shkreli Reveals Short Position
FDA & Biotech
2mo ago

Capricor Stock Plummets 22% After Martin Shkreli Reveals Short Position

The controversial investor, known as 'Pharma Bro,' targeted the biotech on the same day it released positive platform data, creating a new challenge for the embattled drugmaker.

Clearside Biomedical Plunges 68% After Filing for Chapter 11
FDA & Biotech
2mo ago

Clearside Biomedical Plunges 68% After Filing for Chapter 11

The biopharmaceutical company will pursue a strategic sale of its assets, including its commercial eye-disease therapy, through a court-supervised auction.

Biogen Shares Climb as Novo Nordisk's Alzheimer's Drug Fails
FDA & Biotech
2mo ago

Biogen Shares Climb as Novo Nordisk's Alzheimer's Drug Fails

The setback for Novo Nordisk's oral semaglutide removes a key competitor, strengthening the market position of Biogen's Alzheimer's treatment, Leqembi.

Capricor Therapeutics Stock Plummets 17% Despite Positive Data News
FDA & Biotech
2mo ago

Capricor Therapeutics Stock Plummets 17% Despite Positive Data News

The sharp sell-off in the biotech firm's shares suggests investor skepticism over preclinical results for its exosome drug-delivery platform.

Harmony Biosciences Jumps on Positive Drug Study Results
FDA & Biotech
2mo ago

Harmony Biosciences Jumps on Positive Drug Study Results

Shares rise after pivotal study for a new formulation of its narcolepsy drug WAKIX meets primary goals, paving the way for a 2026 regulatory filing.

Invivyd Shares Climb on Plans for New 'Best-in-Class' RSV Drug
FDA & Biotech
2mo ago

Invivyd Shares Climb on Plans for New 'Best-in-Class' RSV Drug

The biotech company aims to challenge AstraZeneca and Sanofi in the lucrative pediatric respiratory virus market, but targets a lengthy 2026 timeline for its next regulatory step.

Bayer Stroke Drug Succeeds in Pivotal Trial, Boosting Pharma Pipeline
FDA & Biotech
2mo ago

Bayer Stroke Drug Succeeds in Pivotal Trial, Boosting Pharma Pipeline

Asundexian, a next-generation anticoagulant, significantly cut stroke risk without increasing major bleeding, marking a key victory after a prior setback.