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Theratechnologies to Resume Egrifta Production

[ Price : $8.95]

Theratechnologies plans to resume production of its drug Egrifta for patients with excess stomach fat due to HIV medications after...

FDA OKs New Vial Size for Hizentra

[ Price : $8.95]

FDA approves a CSL Behring supplemental BLA for a 10 g (50 mL) vial size for Hizentra (immune globulin subcutaneous - human).

Siemens Class 1 Recall of MicroScan Products

[ Price : $8.95]

Siemens begins a Class 1 recall of its MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels because they are report...

FDA Priority Review for Takeda Colitis BLA

[ Price : $8.95]

FDA grants Takeda Pharmaceutical Co. a priority review for a BLA for its new investigational drug vedolizumab, indicated for treat...

Rockwell Medicals Iron Replacement Meets Endpoints

[ Price : $8.95]

Rockwell Medical says its investigational iron-delivery drug SFP for chronic kidney disease patients on hemodialysis met primary a...

Takedas Alogliptin Shows No Increased Cardio Risk for Diabetics

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Takeda Pharmaceutical reports positive results from its EXAMINE cardiovascular safety outcomes trial of Type 2 diabetes treatment ...

Myriad Provides Test for AZ Breast/Ovarian Cancer Trial

[ Price : $8.95]

Myriad Genetics collaborates with AstraZeneca to provide companion diagnostics for a Phase 3 clinical trial of AstraZenecas olapar...

FDA Specifies DUNS as Drug Establishment Identifier

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FDA issues a guidance specifying the DUNS number as the unique facility identifier for drug establishments as required by FDASIA.

MAPP on Non-archivable Electronic Materials

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CDER releases a MAPP on its policy for using electronic materials that are in non-archivable formats.

Titan Seeks FDA Input on Probuphine NDA Rejection

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Titan Pharmaceuticals asks FDA for a Type B meeting to discuss its rejected NDA on Probuphine, an investigational subdermal implan...