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The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..

Verseon has acquired Edammo, an artificial intelligence-focused company, to deepen its own AI-based drug discovery platform. Financial terms were not disclosed.

The Biotechnology Innovation Organization, Passage Bio and Palisade Bio saw leadership shakeups at the top, while Maze Therapeutics, Cerecin and more appointed new chief medical officers.

Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.

Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.

GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.

One year after BridgeBio won accelerated approval for liver cancer drug Truseltiq (infigratinib), the company is pulling a planned Phase III program due to its partner’s decision to discontinue the drug.

Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.

Odyssey Therapeutics raised $168 million in a Series B financing round, which will be used to advance its portfolio of immunomodulators and oncology therapies.

The internet and “common wisdom” aren’t always right. Here are some of the top myths about three common conditions, and the truth from leading experts in their fields.

As part of a realignment, GreenLight Biosciences is cutting staff by about 25%, the company announced Wednesday.

Terray Therapeutics and Calico Life Sciences struck a research and development collaboration focused on the development of small-molecule therapeutics for age-related diseases.

• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions

• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses

Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships

Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio