The FDA’s Commissioner’s National Priority Voucher program has been steeped in controversy since its inception. Now, Sanofi has asked that one of its applications be taken out of the fast-track program, according to Stat. More: Sanofi asks to pull Tzield
read moreIn a bid to better deploy its boots-on-the-ground resources, the FDA is rolling out a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to complement its traditional site visits. More: FDA rolls out 1-day assessment pilot
read moreAfter several consecutive quarters on the backfoot, Danish drug juggernaut Novo Nordisk is receiving warmer feedback on its starting performance in 2026, thanks in no small part to its head start over rival Eli Lilly in the burgeoning market for
read moreThe FDA-conducted studies reportedly found COVID vaccines and GSK’s shingles vaccine Shringrix safe and effective, according to The New York Times. More: FDA blocks publication of COVID, shingles vaccine safety studies: NYT Source: fierce
read moreCell and gene therapy developers must build continuity of engagement to create trust in the modalities, according to a report by Bayer’s venture capital wing. More: Bayer diagnoses how to build trust in cell and gene therapies Source: fierce
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