For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...

Sale follows recent Electronic Catalog (ECAT) listing approval by U.S. Defense Logistics Agency Symvess now available to U.S. Department of Defense and U.S. Department of Veterans Affairs facilities ...

The FDA has begun accepting applications for a priority pathway designed to slas | The FDA has begun accepting applications for a priority pathway designed to slash review times to one to two months, ...

A Mayo Clinic study confirmed the accuracy of a new FDA-approved blood test for early detection of Alzheimer's disease.

Whether it involves the DEA's much-publicized marijuana rescheduling efforts or MMJ BioPharma's lawful pursuit of a federal registration to conduct FDA-authorized clinical trials, one immovable ...

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...