Petition filed in US Second Circuit asking for reconsideration of decision allowing plaintiffs’ experts to testify addresses ...

Japan’s latest health and drug spending figures illustrate the dilemma of balancing drug pricing policy with the medical ...

FDA commissioner nominee Heidi Overton met with CHPA leadership earlier this year, signaling Rx-to-OTC switch as a priority ...

A 50% application fee reduction for sponsors with at least one Phase I trial “anchored” in the US is loosely defined, easily ...

Industry analysts at RAPS Convergence said CDRH has weathered 2025's turbulence well, but onboarding a large new cohort with ...

Sen. Cassidy, despite reservations about Overton's managerial experience and vaccine stance, proceeds toward a hearing amid ...

The Swiss drugmaker said it would discontinue development of the drug in amyotrophic lateral sclerosis after it failed to ...

The European Medicines Agency is expected to uphold its previous recommendation against EU marketing approval for MaaT Pharma ...

CMS is phasing out the alternative NTAP pathway on disputed financial grounds, threatening the commercial rationale for FDA ...

Zealand Pharma’s glepaglutide is among three products scheduled for oral explanation meetings with the European Medicines ...

Leaders at Merck & Co., Pfizer, Johnson & Johnson and AbbVie appear to see potential upside from US policies at the moment, ...

Amgen has not written off its Lp(a) inhibitor olpasiran after Novartis’s pelacarsen failure, but R&D leader James Bradner ...