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
Decision on EU marketing authorisation for this population expected by September 2024
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Heavy bleeding after giving birth is globally a leading cause of death in new mothers
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms
EMA recommended 30 veterinary medicines for marketing authorisation in 2025
Experts caution that realizing AI’s potential requires careful management and risk mitigation
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