FDA's NDA And BLA Approvals: Lonhala Magnair, Ozempic
Original new drugs and biologics recently approved by US FDA.
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Glenmark’s nebulized, long-acting muscarinic antagonist for COPD has hit the Indian market. Delivered via a novel mesh nebulizer, it is seen as likely catering to a relatively small patient group.
Lilly’s migraine prevention therapy, galcanezumab, is among the nine new products that companies have submitted to the European Medicines Agency for evaluation in recent weeks.
Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.