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

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

Lumipulse, a non-invasive, blood test can help diagnose Alzheimer’s disease in adults aged 55 and above by measuring the ...

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

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

Officials with the FDA have approved the first generic robenacoxib tablets for the control of postoperative pain and ...

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 ...