Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram (g) formulation of Fibryga ...

The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency.

Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

Investing.com -- The U.S. Food and Drug Administration (FDA) approved Zycubo (copper histidinate) injection on Monday as the ...

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel ...

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

The weight loss drug Wegovy is now available as a tablet in more than 70,000 U.S. pharmacies as well as select telehealth ...

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...

FDA approvals in 2025 introduced novel therapies and devices across ophthalmic subspecialties, emphasizing sustained efficacy ...

The FDA’s Office of Prescription Drug Promotion asserted that BeOne’s Teams backgrounds made benefit claims without providing ...