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FDA releases the form FDA-483 with 12 observations from a 2023 inspection at Chinas Nanchang Anobri drug manufacturing facility.[ Price : $8.95]
FDA approves a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with...[ Price : $8.95]
FDA issues Zealand Pharma a complete response letter on its NDA for dasiglucagon and its use in preventing and treating hypoglycem...[ Price : $8.95]
FDA accepts a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe hot flashes asso...[ Price : $8.95]
FDA grants exemptions to Drug Supply Chain Security Act eligible connected trading partners, pushing the implementation date for e...[ Price : $8.95]
GSK says trial data show its Arexvy protects through three complete RSV seasons.[ Price : $8.95]
FDA says six products manufactured at Baxters hurricane-damaged facility in North Carolina are now on the shortage list.[ Price : $8.95]
Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act...