NICE (UK): Guselkumab can be used as an option for treating moderately to severely active ulcerative colitis in adults when: i) a conventional treatment, biological treatment or Janus… read more.
NICE (UK): Tarlatamab should not be used to treat extensive-stage small-cell lung cancer in adults whose cancer has progressed after 2 or more lines of treatment, including platinum-based… read more.
Alexion, AstraZeneca Rare Disease, will present four abstracts, including one oral presentation, from its leading rare neurology portfolio at the European Committee for Treatment and Research in Multiple… read more.
Valneva SE announced that the EMA will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a systematic review of Valneva’s single-dose chikungunya… read more.
Phio Pharmaceuticals Corp. is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL® siRNA gene silencing technology to eliminate cancer. Phio announced that Phio Pharmaceuticals is a presenting… read more.
Moderna Inc. announced that the FDA has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax and mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2… read more.
Eli Lilly and Company announced positive topline results from the primary overall survival (OS) analysis of the Phase III monarchE trial. Treatment with two years of Verzenio plus… read more.
Boehringer Ingelheim’s Hernexeos (zongertinib tablets) has been approved as monotherapy by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or… read more.
Tonix Pharmaceuticals Holding Corp. announced that the FDA approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic… read more.
Alvotech and Advanz Pharma announced that the European Commission has approved Mynzepli as a biosimilar to Eylea (aflibercept), in a pre-filled syringe and vial. The centralized marketing authorization… read more.
Novavax, Inc. announced that the FDA has approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years… read more.
Agios Pharmaceuticals Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of Pyrukynd (mitapivat), an… read more.
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