Page 28 - Priority Review News Today

ROCKVILLE, Md. and SUZHOU, China, Nov. 30, 2023 /PRNewswire/ -- Innovent Biologics, Inc. , a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality...

/PRNewswire/ -- The "DUPIXENT Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.coms offering. DUPIXENTs potential as a...

If approved, this combination will become a first-line treatment option for patients who are cisplatin eligible.

The FDA has granted Priority Review to the sBLA for Keytruda plus Padcev for first-line treatment of locally advanced or metastatic urothelial cancer.

DUBLIN, Dec. 1, 2023 /PRNewswire/ -- The "DUPIXENT Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering. DUPIXENT's potential as a game-changer extends

/PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced that on November...

Lund, Sweden, November 29, 2023. Hamlet BioPharma AB (publ), the pharmaceutical company with a strong portfolio of projects for the treatment of cancer and infections, announces today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its drug candidate Alpha1H for the treatment of non-muscle invasive bladder cancer. The U.S. FDA Fast Track Designation accelerates the approval process for Alpha 1H and potential for reaching the US market. 

The FDA approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is a new molecular entity and the first drug to be approved for the treatment of patients with desmoid tumors, a subtype of soft tissue sarcomas.

- Pivotal Phase 3 Study of Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer Initiated in September 2022 - - Phase 2 Trial of Olvi-Vec- Demonstrated Clinical Reversal of Platinum Resistance...

- PDUFA target action date is May 25, 2024 -