With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design.

Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.

On the last day of the year, shares of Axsome Therapeutics Inc. rose 22% on news that the U.S. FDA accepted and granted priority review of the company’s supplemental NDA for AXS-05 to treat Alzheimer’s disease agitation, a $1 billion-plus opportunity, scheduling the PDUFA date for April 30.

The U.S. FDA dashed hopes that Corcept Therapeutics Inc. might be able to launch its selective glucocorticoid receptor antagonist in two indications in 2026, issuing a complete response letter for relacorilant for use in patients with hypertension secondary to hypercortisolism, also known as Cushing syndrome. Focus is now on the July 2026 PDUFA date, as Corcept seeks approval for the same drug as a treatment for patients with platinum-resistant ovarian cancer.

The U.S. FDA has approved its first pharma treatment in more than 40 years for motion sickness. The green light for Nereus (tradipitant), from Vanda Pharmaceuticals Inc., was based on three clinical studies, all pivotal, including two phase III real-world trials with patients on boats and another supporting study.

If the 2025 U.S. life sciences regulatory scene were to be summed up in one word, it would have to be uncertainty. Two words might be more definitive – chaotic uncertainty.

A federal judge in Maine has put the brakes on a pilot program that would have enabled biopharma companies to offer rebates instead of up-front discounts as part of the 340B program beginning Jan. 1, 2026.

Asia, led by China, is no longer just following global pharma trends. It is helping to shape them, and for investors, innovators and policymakers, the question is no longer whether to engage with Asia, but how to engage wisely in this new, more complex world.

Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration (NMPA) accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review.

U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.