The FDA also cited concerns about the heterogeneity of the trial’s patient population and items related to the confirmatory trial study design. However, the agency did not mention safety issues.

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing ...

Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with side effects, proposed dosing and a lack of diversity in GSK's trials.

The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is ...

The agency halts muscular dystrophy drug trials after 3 deaths from liver failure.

Kezar Life Sciences Announces FDA Has Lifted Partial Clinical Hold on PORTOLA Phase 2a Trial Evaluating Zetomipzomib for the Treatment of Patients with Autoimmune Hepatitis Kezar Life Sciences ...

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. FDA ...

FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

Oruka Therapeutics, Inc. has received FDA clearance to proceed with its Phase 2a trial of ORKA-001, a long-acting anti-IL-23p19 antibody, for moderate-to-severe psoriasis in a study named EVERLAST ...

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older against fleas and ticks.