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The company’s second antibody-drug conjugate deal of 2023, with Shanghai-based LaNova Medicines, adds a potential first-in-class GPRC5D-directed ADC for multiple myeloma.

Veozah, an oral once-daily medication, is the first FDA-approved NK3 receptor antagonist for hot flashes, a common symptom of menopause that can affect health and quality of life.

Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.

Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.

Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.

Lawmakers on Thursday voted 18–3 to increase oversight of pharmacy benefit managers and limit their practice of spread pricing, when PBMs charge payers for drugs more than they pay pharmacies.

The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.

The regulator in a Complete Response Letter rejected ImmunityBio’s bladder cancer hopeful due to deficiencies with the company’s third-party contract manufacturer.

The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.

As insulin prices skyrocket, pharmas and PBMs faced pointed critique from the Senate HELP Committee, led by Sen. Bernie Sanders (I-VT).

The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.

Colchicine, a drug used to treat gout, saw a 16-fold price increase since the FDA changed its policy toward single-ingredient oral colchicine products, which had previously been available generically.

• 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