Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater than currently accepted.

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of the monoclonal antibody drug class that has led to several deaths.

By Kingsley Webora TANKEH Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and medium-sized enterprises (SMEs) from obtaining the ...

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

FDA raised safety concerns for Vyvgart Hytrulo in CIDP, while Argenx moves ARGX-119 into late-stage trials for rare neuromuscular disease.

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 ...