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Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)
Shots: FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible  pts with MIBC, before the PDUFA action date (Apr 07, 2026) Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B…
November 24, 2025
Boehringer Ingelheim
Boehringer Ingelheim Secures CVMP Positive Opinion for Vaxxitek HVT+IBD+H5 and Vaxxinact H5 Vaccines Against Avian Influenza
Shots: The CVMP has recommended Vaxxitek HVT+IBD+H5 & Vaxxinact H5 for active immunization of birds against H5 avian influenza virus Vaxxitek HVT+IBD+H5 is a trivalent vaccine providing single-dose protection against Marek’s disease, Infectious Bursal Disease, & H5 avian influenza in chickens & turkeys, while Vaxxinact H5 is an inactivated vaccine that protects chickens, turkeys, & ducks…
November 21, 2025
Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic
Shots: The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC Oncomine Dx Target Test, first…
November 21, 2025
Intelerad
GE HealthCare to Acquire Intelerad for $2.3B
Shots: GE HealthCare has entered into an agreement to acquire Intelerad, expanding its cloud-enabled & AI-powered solutions portfolio As per the deal, GE HealthCare will acquire Intelerad for a purchase price of $2.3B in cash; closing is expected in H1’26 Acquisition will add Intelerad’s cloud-enabled radiology & cardiology imaging platforms & outpatient enterprise workflow solutions…
November 21, 2025
Valo & Merk KGaA
Valo Health Inks Over $3B Partnership with Merck KGaA to Advance Novel Therapies for Neurodegenerative Disorders
Shots:  Valo Health has entered into a strategic collaboration with Merck KGaA to accelerate therapeutic discovery for Parkinson’s disease & related neurodegenerative disorders As per the deal, Valo Health will receive an upfront & milestone payment totaling over $3B, with royalties & R&D funding Collaboration will use Valo’s AI-enabled human causal biology platform to discover &…
November 21, 2025
Formycon Launches Epruvy (Biosimilar, Lucentis) in the Germany
Shots:  Sandoz commercializes Epruvy (Biosimilar, Lucentis) across Germany in PFS and vial forms, following an agreement with Formycon and Bioeq   Epruvy (ranibizumab)was approved by the EMA in Sep'24 to treat severe visual impairments like nAMD and other retinopathies and is marketed by Sandoz in Germany under a Bioeq license   Epruvy is available in vials and pre-filled syringes, offering a convenient treatment option in Germany  Ref: Formycon | Image: Formycon  | Press Release Related…
November 20, 2025
Alvotech and Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the EC Approval to Treat Several Chronic Inflammatory Diseases
Shots: The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states Approval was based on extensive data, incl.…
November 20, 2025
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