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
Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector
Approval marks Venus Remedies’ first anti-infective marketing authorization in Indonesia and enables the country’s first generic entry for this critical antibiotic combination
The acquisition combines Firstsource’s market-leading AI and automation capabilities with TeleMedik’s operational footprint in Puerto Rico
This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo to patients in France, Denmark, Iceland, Sweden, Finland and Norway
InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
Applications include detailed scientific rationale and supporting clinical evidence
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