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Latest From Sanofi

Keeping Track: Return & Renewal At US FDA

Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus

Abrysvo is recommended for use in pregnant people 32-36 weeks gestation if administered from September to January. For infants whose mothers were not vaccinated in this window, nirsevimab is recommended for prevention of respiratory syncytial virus infection.

Advisory Committees Vaccines

Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

Clinical Trials Business Strategies

Deal Watch: Merck KGAA Teams With AI Biotechs On Drug Discovery Efforts

Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

Deal Watch Business Strategies
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Vaccines
  • Other Names / Subsidiaries
    • Ablynx N.V.
    • Acambis PLC
    • Avigen Inc.
    • Bioverativ Inc. (True North Therapeutics, Inc.)
    • BiPar Sciences Inc.
    • BMP Sunstone Corporation
    • Canderm Pharma Inc.
    • Celmed BioSciences, Inc.
    • Chattem, Inc.
    • Connaught Laboratories Ltd.
    • Fisons Ltd.
    • Fovea Pharmaceuticals, SA
    • Genfar S.A.
    • Genzyme Corporation
    • Groupe Sanofi
    • Hoechst Marion Roussel
    • Kadmon Holdings, Inc.
    • Kiadis Pharma B.V.
    • Kiadis Pharma N.V.
    • Pluromed
    • Principia Biopharma Inc. Protein Sciences Corporation
    • Rhone-Poulenc Rorer
    • Sanofi-Aventis
    • Sanofi-aventis Groupe
    • Sanofi Pasteur MSD
    • Shantha
    • Synthorx, Inc. (THOR)
    • TargeGen, Inc.
    • Thunder Acquisition
    • Tidal Therapeutics
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