fda-and-biotech News
Amneal Shares Hit 52-Week High on FDA Biosimilar Approval
The drugmaker gains FDA approval for two biosimilars targeting blockbuster drugs Prolia and XGEVA in a U.S. market worth over $5 billion annually.
Ginkgo Bioworks Stock Jumps 8.6% on Cancer-Screening Pill Project
The biotech firm is partnering with Carnegie Mellon on an ARPA-H funded initiative to develop an at-home, non-invasive diagnostic an orally administered pill.
Gilead Bets on New Herpes Drug Class in Assembly Bio Licensing Deal
The virology giant will pay $35 million upfront for two candidates with potential for once-weekly oral dosing, aiming to disrupt a market that hasn't seen innovation in decades.
AstraZeneca to Withdraw Andexxa in U.S. After FDA Finds Fatal Clot Risk
Post-marketing study revealed a more than twofold increase in thrombosis-related deaths, prompting the withdrawal of the bleeding-reversal agent acquired in a $1.4 billion deal.
Abbott Shares Rise on FDA Approval of New Heart Rhythm Device
The Volt PFA System enters a competitive, fast-growing market for atrial fibrillation treatment, challenging rivals Boston Scientific and Medtronic.
Cassava Sciences Stock Plummets 25% on FDA Clinical Hold
The FDA has halted the trial of simufilam for epilepsy, the same drug previously at the center of the company's failed Alzheimer's program.
Galectin Plunges 34% After FDA Setback for Liver Drug Belapectin
Regulatory uncertainty clouds the future of the company's lead MASH drug candidate after the agency opts for a written response over a key trial design meeting.
Outlook Therapeutics Slides Despite Looming FDA Decision
Shares drop over 8% as investors weigh a wider-than-expected annual loss against the critical year-end regulatory deadline for its key eye drug, ONS-5010.