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

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

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

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

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

The FDA has approved a blood test to help diagnose Alzheimer's disease, and doctors explain how it works and why it can lead ...

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

Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are ...

On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

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

Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...