News FDA seeks input into 'opaque' priority voucher scheme FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality.
News FDA publishes advice on animal testing alternatives New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.
News First MHRA/NICE aligned guidance due in June The aligned regulatory pathway for UK drugs regulator MHRA and reimbursement authority NICE gets underway on 1st April.
News Novo rapped by FDA for not reporting drug adverse effects Novo Nordisk has been sent a warning letter from the FDA for violations of postmarketing adverse drug experience (PADE) regulations.
News FDA cuts testing requirements for biosimilars once again The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.
News CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.
News Lilly's 'triple G' retatrutide aces crucial obesity trial Lilly's retatrutide achieved weight loss of more than 30% at two years in a new trial, firming up its credentials as a next-generation obesity drug.
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