Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.
On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...
AbbVie agreed to acquire a device manufacturing facility in Tempe, Ariz., and the rights to the SmartDose 3.5 milliliter drug-delivery system from West Pharmaceutical Services as part of a deal worth ...
Pharmaceutical giant Eli Lilly is bringing a major investment to Goochland County. On Tuesday, Sept. 16, the drug maker announced plans to build a $5 billion manufacturing facility in Goochland's West ...
M arking a significant expansion of the company’s global footprint and long-term commitment to the U.S. market, Samsung Biologics America (SBA) has entered into an agreement with GSK to acquire 100% ...
APEX, N.C., Jan. 16, 2026 /PRNewswire/ -- Apiject Holdings, Inc. today announced the signing of a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina. The ...
ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Join us Jan. 14 for a virtual discussion about our Rx ...
Cuban urges FDA fee waiver to boost US generics manufacturing Cost Plus Drugs plans to boost US production if fees are waived FDA charges $360,000 per generic drug approval application Trump promised ...
A South Korean biomanufacturing giant is set to purchase its first drug production facility in the U.S. for a sum worthy of its tech giant parent. Samsung Biologics is the world’s largest contract ...
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