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Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.

Ivonescimab’s progression-free survival data in non-small cell lung cancer bode well for an upcoming overall survival readout, according to Truist analysts, who noted that “OS is likely to be statistically significant” in favor of the PD-1/VEGF bispecific.

Several sources are speculating that the potential buyer could be Eli Lilly, despite the breakdown of the pharma’s partnership with Nektar over atopic dermatitis therapy rezpeg.

Rybelsus can now be used as a primary or secondary prevention pill to lower the risk of major adverse cardiovascular events in at-risk patients with type 2 diabetes.

Glaukos’ Epioxa allows cross-linking therapy for keratoconus without requiring an incision. The biotech expects to launch the drug early next year.

Recent headlines proclaim a ‘potential’ or ‘functional’ cure for multiple myeloma, but the fight against the disease must continue.

After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain.

CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker.

Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer.

The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.

With more than $1.5 billion on the line, Gilead looks to bolster its CAR T portfolio.

EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza.

• 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