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A Massachusetts federal court dismisses a Takeda whistleblower case alleging the company failed to report adverse events involving...[ Price : $8.95]
Merck submits a standard review NDA for suvorexant, a controlled substance drug indicated for treating insomnia.[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says a Curosurf pitch letter and news release omit important risk information and incl...[ Price : $8.95]
FDA appeals a federal judges ruling that would ban use of foreign-made sodium pentothal in state corrections system execution leth...[ Price : $8.95]
FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 12/7 to discuss Zogenix Inc.s NDA for Zohydro ER for mana...[ Price : $8.95]
FDA grants approval with conditions to Kips Bay Medical for an Investigational Device Exemption to include four U.S. study sites o...[ Price : $8.95]
CBERs Nicole Trudel tells the RAPS annual meeting that process validation issues are the most common she finds in biologics pre-li...[ Price : $8.95]
FDA approves a Berlin Heart humanitarian device exemption for the Excor Pediatric System, a device intended to support the weakene...