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CDER Approvals Up 30% in 2014: Jenkins

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CDER Office of New Drugs director John Jenkins says the Center has approved 35 new molecular entity submissions through 12/3, a 30...

Approved Cattle FSH Drug Available

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FDA says it has approved Bioniche Animal Healths Folltropin for use to reduce superovulation for beef and dairy heifers and cows.

FDA Approves Medtronic Left Ventricular Leads

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FDA approves a Medtronic PMA for two additional Attain Performa left ventricular quadripolar leads, which can be paired with the M...

Pfizerpen Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Pfizerpen Pfizerpen (penicillin G potassium) Injection, 1 million units/vial was not ...

Guidance on BE Studies for Budesonide ER Tablets

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Federal Register Notice: FDA releases a draft guidance: Bioequivalence Recommendations for Budesonide Extended-Release Tablets.

FDA Accepts ArmaGen IND Hunter Syndrome Therapy

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FDA accepts an ArmaGen, Inc. IND application for its AGT-182 for treating Hunter syndrome.

FDA OKs WaterWear for Cochlear Implant Processor

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FDA approves Med-El USAs WaterWear submergible waterproof cover for the Rondo Cochlear Implant Audio Processor.

Merck Reports Positive Results with Keytruda in Breast Cancer

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Merck says that early study findings involving Keytruda (pembrolizumab) in PD-L1 positive, advanced triple-negative breast cancer ...

Boston Therapeutics IND for Type 2 Diabetes Therapy

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FDA accepts a Boston Therapeutics IND for BTI-320 for Type 2 diabetes and weight management.

FDA Grants BioMarin Orphan Drug for Sanfilippo Syndrome

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FDA grants orphan drug designation to BioMarin Pharmaceutical for BMN 250 to treat Sanfilippo Syndrome Type B or Mucopolysaccharid...