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Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.

If you’ve recently lost your job, BioSpace has provided a guide to confidentiality agreements and severance packages so you can feel confident making your next career move.

Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.

The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.

The discovery of novel Alzheimer’s biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics.

Structure Therapeutics expects to bring in $161.1 million from an upsized IPO, announced Friday.

Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.

Keytruda could be on its way to snagging another indication as a first-line therapy for endometrial cancer after the company announced positive Phase III results Friday.

Magenta Therapeutics is cutting about 84% of its workforce after a patient’s death halted a Phase I/II trial in acute myeloid leukemia.

Patient Square Capital announced a record-breaking inaugural fund totaling $3.9 billion, proving even in an unstable economy, there’s still money to be made.

Wednesday, the FDA approved GSK’s daprodustat, now to be marketed as Jesduvroq, for the treatment of anemia due to chronic kidney disease in adult patients.

Karuna Therapeutics acquired exclusive rights to Goldfinch Bio’s investigational TRPC4/5 channel candidates in a deal potentially worth $520 million.

• 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