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FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingre...[ Price : $8.95]
A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vi...[ Price : $8.95]
FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocereb...[ Price : $8.95]
An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can...[ Price : $8.95]
Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy dru...[ Price : $8.95]
Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to ...[ Price : $8.95]
Otsuka ICU Medical recalls (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap labe...