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The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.

In a lawsuit filed Monday, Nektar Therapeutics accused Eli Lilly of scheming to ensure rezpegaldesleukin would not succeed after acquiring a competing medicine.

The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.

Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.

The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.

A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff.

Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.

Thursday, Gilead Sciences reported lower second-quarter profit due to a drop in sales of the company’s Veklury antiviral and a $525 million legal settlement, while slightly raising its sales outlook for the year.

The market opportunity for pulmonary arterial hypertension drugs stretches well beyond the 500–1,000 Americans diagnosed with the disease each year—and biopharma is taking note.

For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.

Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.

The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.

• 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