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Baxter BLA for New Factor VIII Submitted

[ Price : $8.95]

Baxter International files a BLA for OBI-1, a recombinant antihemophilic porcine sequence factor VIII for treating patients with a...

CGMP Violations Found at Ameriderm

[ Price : $8.95]

FDAs New Jersey District Office warns Ameriderm Laboratories about CGMP violations in its production of drug products.

Multiple Violations Found at Sharplight Technologies

[ Price : $8.95]

FDA warns Sharplight Technologies about regulatory violations in its manufacturing of powered surgical laser instruments.

FDA Panel Backs Takeda BLA for Crohns, Ulcerative Colitis

[ Price : $8.95]

A joint FDA advisory committee votes to recommend approval for a Takeda Pharmaceutical BLA for vedolizumab and its use in treating...

FDA Inspection Finds Violations at Jubilant HollisterStier

[ Price : $8.95]

FDAs Seattle District Office warns Jubilant HollisterStier about CGMP violations in its manufacturing of finished pharmaceuticals....

PhRMA Wants FDAMA Section 114 Guidance

[ Price : $8.95]

PhRMA calls on FDA to issue guidance on how drug companies can disseminate healthcare economic data under FDAMA Section 114 withou...

AbbVie Study Shows 96% Response with Genotype 1 Hepatitis C

[ Price : $8.95]

AbbVie reports positive data from its SAPPHIRE-II study of a three direct-acting-antiviral regimen plus ribavirin in patients with...

FDA OKs New Dose for Zogenix Migraine Treatment

[ Price : $8.95]

FDA approves a Zogenix supplemental NDA for a 4 mg dose of Sumavel DosePro Needle-free Delivery System.

CDER Focusing on Increasing Data Integrity Problems

[ Price : $8.95]

CDER Office of Compliance deputy director Ilisa Bernstein says the Center plans to place more attention on data integrity problems...

FDA Sends Info on Device QSRs to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on medical device current good manufacturing practice to...