Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.
FDA posts final guidance on remanufacturing medical devices Read More »
Two of the five fatalities were found to be unrelated to MacroGenics’ investigational antibody-drug conjugate vobra duo, while the other three are still under investigation.
Five Deaths in Prostate Cancer Trial Send MacroGenics’ Stock Plummeting Read More »
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use.
Cell and Gene Therapies Still Have Long Way to Go in Fulfilling Promise Read More »
On April 29th, 2024, the U.S. FDA granted full approval for Seagen Inc.’s TIVDAK® (tisotumab vedotin) targeting tissue factor (TF) for the treatment…
FDA-approved TIVDAK®: Targeting Tissue Factor in Cervical Cancer Read More »
With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.
Royalty Pharma Drops $525M for Royalties and Milestones on Sanofi-Licensed MS Therapy Read More »
With 15 patients started across its three gene therapies, bluebird bio claims a 138% year-over-year revenue growth and aims to initiate up to around 100 new patients in the current year.
Bluebird Boasts Nearly 140% Revenue Jump, Still Misses Target Read More »
Anticipating approval for its COPD therapy ensifentrine, Verona has entered into a $650 million financing deal with Oaktree Capital Management and OMERS Life Sciences.
Protalix BioTherapeutics, Inc., a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, reported financial results for the quarter ended March 31, 2024, and provided a business and clinical update.
Protalix BioTherapeutics Reports First Quarter 2024 Financial and Business Results Read More »
Ribobay Pharma, a leading Chinese biopharmaceutical contract research, development, and manufacturing organization and a spin-off company of General Biol Co., Ltd, will provide cGMP-level oligonucleotide CRDMO services to the world using Cytiva’s first FlexFactory platform for oligo manufacturing.
Las estrellas brillan como faros en la oscuridad, ofreciendo pistas cruciales sobre la historia y la evolución del universo. Uno de los enigmas más fascinantes que los astrónomos han perseguido durante siglos es el desafío de determinar la edad de estas incandescentes esf …
