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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]
FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, includi...[ Price : $8.95]
Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden depa...[ Price : $8.95]
FDA approves a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tr...[ Price : $8.95]
Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase...[ 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...