The US drug regulator has missed a deadline for granting full approval to Novavax's COVID-19 vaccine, the company said ...

Patient engagement through advisory boards, surveys, and listening sessions can help address industry challenges such as ...

The University of Kentucky's Center for Clinical and Translational Science brought together around 1,000 clinicians, ...

The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug ...

Soleno Therapeutics awaits FDA decision on its drug for Prader-Willi Syndrome, facing challenges amid Trump Administration's government changes.

Cancer drugs with higher clinical benefit in pivotal trials and without major safety concerns achieve full US Food and Drug Administration (FDA) approval more quickly. Drugs demonstrating ...

Amvuttra is entering the ATTR cardiomyopathy market behind products from Pfizer that have become the standard of care and a BridgeBio Pharma drug approved last fall. But Amvuttra introduces a new ...

The U.S. Food and Drug Administration has granted approval to a new antibiotic to treat urinary tract infections in women and adolescent girls. The drug is made by British pharmaceutical company GSK.

The U.S. Food and Drug Administration has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra (vutrisiran), is made by Alnylam ...

The Food and Drug Administration on Tuesday approved the first drug in a new class of antibiotics for treating urinary tract infections — the first time that’s happened in nearly 30 years.