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
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
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