FDA's NDA And BLA Approvals: Idhifa, Mavyret, Vyxeos
Original new drugs and biologics recently approved by US FDA.
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In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.
The UK life sciences trade group says the “ill-considered” guidance will result in duplicative and costly repetition and dent industry’s confidence in the government’s competence.
Sponsors of new and existing medicines in New Zealand will have to update their product labels within specified deadlines to include warning statements about certain allergens.