The FDA approved the first drug from an emerging class of medicines for patients with a chronic, autoimmune kidney disease.

The U.S. Food and Drug Administration has approved Otsuka's injectable drug to treat patients with a potentially ...

Novartis is pricing Itvisma at a wholesale acquisition cost of $2.59 million, a company spokesperson told Fierce Pharma. At ...

The FDA has approved Hyrnuo for some with locally advanced or metastatic non-squamous non–small cell lung cancer with ...

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb) as the first interchangeable biosimilar to ...

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...

In 2024, the FDA granted a record 63 designations to antibody drug conjugates (ADCs), nearly double the previous high of 35 ...

Learn why understanding the FDA’s 510(k) database is essential for every MedTech manufacturer. Discover how it supports competitive analysis, regulatory planning, faster approvals, and smarter product ...

The U.S. Food and Drug Administration has approved Novartis' gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday.

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

The clinical trials new drugs and devices must undergo for approval by the U.S. Food and Drug Administration hold the drugs to varying degrees of approval, according to a study published in the ...