A dramatic pullback in public biotech investment catalyzed by economic and regulatory upheaval is putting even more stress on ...

Prothena will cut 63% of its workforce and evaluate a “range of business options.” Elsewhere, Zealand revealed data for a ...

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

The Swiss drugmaker said it was “encouraged” by the signs of effectiveness of the drug, developed by biotech Prothena, showed ...

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market ...

With backers such as Regeneron’s venture arm, Actio Biosciences is working on medicines that counter a wide range of ...

In what one analyst described as an “unremarkable” outcome, the brain drug developer is being acquired for just $8.50 per ...

The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned ...

The funds will support Phase 2 testing of a drug the company believes to be able to safety home in on AMPA receptors, an ...

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or ...

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...

Another person treated with Elevidys suffered acute liver failure, leading Sarepta to discontinue treatment in certain ...