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. Read More
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. Read More
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. Read More
It’s been a year of two halves in Europe, with early optimism that the biotech sector had recovered from the post-pandemic funding drought being crushed by an investment slowdown from June onward. Read More
Wife-and-husband team, J. Jean Cui and Y. Peter Li, launched Blossomhill Therapeutics Inc. in mid-2020 to focus on next-generation, macrocyclic inhibitors against oncology targets. The couple had planned to take some time off to rest and do a little traveling, but then the pandemic hit. “This was a great time [to start a new company],” Cui told BioWorld. “Nothing to do but reading and thinking.” Read More
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. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Cogent, Hutchmed, Unicycive. Read More
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