News | January 01, 2026
Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
The accelerated review covers WCK 5222 for multiple critical infections
The accelerated review covers WCK 5222 for multiple critical infections
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities
Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option
Full approval will depend on verification of clinical benefit in a confirmatory trial
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
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