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FDA Clears StelKast EXp for Knee System

[ Price : $8.95]

FDA clears a StelKast 510(k) for the antioxidant material EXp and its use with the Proven Gen-Flex Total Knee System.

MAPP on Non-archivable Electronic Materials

[ Price : $8.95]

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

[ Price : $8.95]

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

clat Wants Unapproved Drugs Off Market

[ Price : $8.95]

clat asks FDA to apply regulations on unapproved new drugs to five companies marketing unapproved neostigmine methylsulfate produc...

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

[ Price : $8.95]

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...