23 stories found
The U.S. Food and Drug Administration has approved updated COVID-19 vaccines from Pfizer-BioNTech and Moderna, specifically formulated to target the XFG variant for the 2026-2027 season. The decision clears the way for domestic manufacturers to begin distributing the updated shots to healthcare providers.
The agency granted approval for zanidatamab-hrii combined with or without tislelizumab and chemotherapy for HER2-positive gastroesophageal adenocarcinoma.
Orum Therapeutics has announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for ORM-1153, a novel CD123-GSPT1 degrader-antibody conjugate.
The U.S. FDA has listed 12 ongoing foodborne illness outbreaks, including cases of Cyclospora and Salmonella, with the sources of eight outbreaks yet to be identified.
A Yahoo article critically examines the U.S. FDA's recently introduced regulations concerning psychedelic substances, suggesting a complex and potentially problematic approach by the agency.
The U.S. FDA has approved setmelanotide (IMCIVREE) for the treatment of acquired hypothalamic obesity, a significant development in managing the condition.
The U.S. Food and Drug Administration has issued four observations to a formulation unit belonging to a subsidiary of Aurobindo Pharma.
The U.S. Food and Drug Administration has approved a breakthrough pancreatic cancer treatment that clinical trials show extends patient survival to a median of 13.2 months, marking a major advancement for one of the most difficult-to-treat cancers.
The U.S. FDA has granted Orphan Drug Designation to Gamgertamig for its use in treating Pemphigus.
The U.S. FDA has granted approval for Moderna's mRNA flu vaccine, marking the first mRNA-based flu shot to receive such clearance. This approval is considered significant for future vaccine development.
A U.S. FDA advisory panel is set to review seven popular peptides to determine if they can be compounded by licensed pharmacies. Despite potential regulatory hurdles, industry experts anticipate continued strong consumer demand for these substances.
The U.S. FDA has proposed new restrictions on the mass compounding of weight-loss drugs manufactured by Novo Nordisk and Eli Lilly.
A unit of Aurobindo Pharma's arm in Rajasthan, India, has been classified as 'Official Action Indicated' (OAI) by the U.S. Food and Drug Administration.
Boehringer's Hernexeos was one of the 18 drugs selected so far for the FDA Commissioner's National Priority Voucher Program that allows speedy process and cuts the review time to one to two months from the typical 10 to 12 months
The U.S. Food and Drug Administration has reversed its earlier decision and will now review Moderna's application for its modified influenza vaccine.
The U.S. Food and Drug Administration has approved a new once-daily oral medication for advanced pancreatic cancer, marking a significant clinical breakthrough that nearly doubled patient survival rates in trials. The approval has prompted analysts to raise price targets for associated biotechnology firms.
Orum Therapeutics announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for ORM-1153, a novel CD123-GSPT1 degrader-antibody conjugate.
The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based flu vaccine, Fluarix, marking the first mRNA flu shot to be authorized. This new vaccine is specifically geared towards protecting millions of older Americans against influenza.
Merck's new cholesterol pill has received approval from the U.S. Food and Drug Administration (FDA). This powerful new medication is expected to offer a significant treatment option for patients.
The U.S. FDA is initiating a pilot program to monitor clinical trial data in real time, aiming to accelerate drug approval processes.
U.S. FDA says it met with states interested in importing cheaper drugs from Canada The Globe and Mail
Aurobindo Pharma's subsidiary has received approval from the U.S. FDA for its generic version of a Novartis drug, marking a significant development for the company.