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NEWS

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

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Boehringer Ingelheim
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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

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NEWS

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

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Intelerad
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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

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Valo & Merk KGaA
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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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Bayer
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Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for Advanced HER2-mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hyrnuo (BAY 2927088; reversible TKI) under priority review for the treatment of previously treated pts with LA/M NSCLC harboring HER2 tyrosine kinase domain activating mutations; NDA under NMPA’s review Approval was based on the ORR & DoR data from the ongoing P-I/II (SOHO-01) trial assessing Hyrnuo (PO) in…
November 21, 2025

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Astrazeneca
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AstraZeneca Reports the US FDA Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots: The US FDA has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1) Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries, incl. North America, South America, Europe, Asia…
November 20, 2025

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NEWS

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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Merck new
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Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection

Shots: The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537) Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…
November 20, 2025

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