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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.
In 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.
After 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 oral obesity therapies.
The FDA-conducted studies reportedly found COVID vaccines and GSK's shingles vaccine Shringrix safe and effective, according to The New York Times.
Following a series of “most favored nation” pricing deals with 17 large pharma companies, the Trump administration released a report Tuesday projecting potential $529 billion in savings from the policy over the next 10 years.
With commitments to invest more than $50 billion in building up its U.S. manufacturing presence, Eli Lilly has earmarked an additional $4.5 billion to upgrade two of its three planned production facilities in Lebanon, Indiana. The company revealed the new investment at a ribbon-cutting ceremony for its genetic medicine plant in Lebanon, which is the first of the three new facilities to become operational.
With a better-than-expected first quarter in the books, Pfizer—continuing to grapple with the post-pandemic overhang from its COVID-19 franchise—is sticking with the sales forecast it set earlier this year, raising questions from at least one analyst about whether it could have lifted its outlook.
Novartis is continuing its multiyear overhaul with new plans to shutter its production facility in Wehr, Germany, by 2028. The move, announced Tuesday, will eliminate about 220 jobs, according to Novartis.
The German vaccine maker plans to wind down operations at a handful of its sites in Germany plus one in Singapore, putting as many as 1,860 jobs on the chopping block.
Fresh off gaining an FDA expansion for Auvelity as a treatment for agitation associated with Alzheimer’s disease, Axsome Therapeutics has projected peak sales for the non-antipsychotic drug to reach $8 billion.