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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
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