A phase 3 trial of Nektar Therapeutics’ chronic pain asset NKTR-181 has met its primary endpoint. The clinical trial linked the mu-opioid to a statistically…

Array BioPharma has yanked its NDA to the U.S. regulator for its late-stage melanoma candidate binimetinib after the agency told the biotech its phase 3 Nemo…

The FDA has rejected AstraZeneca’s hyperkalemia drug ZS-9 for the second time in 12 months. The news marks a further blow for a program AstraZeneca saw giving…

AveXis has posted top-line data from a phase 1 trial of its gene therapy against spinal muscular atrophy (SMA). All 15 patients were event-free at 13.6 months…

Seres Therapeutics has unveiled the design of a phase 2 trial it thinks could secure FDA approval for its microbiome drug.

President Donald Trump’s first budget will take billions of dollars away from the National Institutes of Health (NIH) as the administration looks to rein in…

Astex Pharmaceuticals has pocketed a milestone payment from Novartis after the latter's cancer drug secured FDA approval.

Karyopharm has seen studies for its big hope selinexor placed on a partial clinical hold, meaning it can no longer recruit new patients, over the FDA’s demands…

President Donald Trump has chosen Scott Gottlieb to run the FDA, setting the stage for faster approvals, greater regulatory transparency.

Regulatory