Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
Company to launch product after the expiry of semaglutide patent in India
This marks the second indication for which gumokimab has gained NDA review acceptance
Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike
The deal to acquire AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m) underscores Bayer’s commitment to expanding in molecular imaging and advancing precision cardiology
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