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The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

Join us in this discussion on how you can optimize your chances of landing a new role despite a highly competitive job market.

Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.

Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio.

Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.

Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure.

The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.

Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.

AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.

Tegoprubart, Eledon Pharmaceuticals’ experimental anti-CD40L antibody, was part of the immunosuppressive treatment regimen used following the first-ever transplant of a kidney from a genetically modified pig to a human.

Oprah Winfrey this week shone the spotlight on these transformative GLP-1 medications. Now, it’s time for Medicare to cover them and expand access to millions of Americans.

Duvyzat, which will be sold in the U.S. by ITF Therapeutics, joins a growing market that includes recently approved gene therapy Elevidys and corticosteroid Agamree.

• 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