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Pfizerpen Not Withdrawn for S&E

[ Price : $8.95]

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Federal Register Notice: FDA releases a draft guidance: Bioequivalence Recommendations for Budesonide Extended-Release Tablets.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

[ Price : $8.95]

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

FDA OKs WaterWear for Cochlear Implant Processor

[ Price : $8.95]

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

House Committee Asks for Lab Test Regulation Input

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The House Energy and Commerce Committee solicits public input on 11 questions about FDA regulation of laboratory-developed tests.

GPhA Backing Biosimilar Substitute Legislation

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Generic Pharmaceutical Association president Ralph Neas says the association is backing compromise legislation to be considered in...

Drug Patent Expiries to Cost Owners $65 bil.: Report

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GlobalData says that upcoming patent expirations for several central nervous system drugs will cost their companies $65 billion in...

Engage Patients, Others with Specific Conditions: Pfizer

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Stakeholders suggest better ways to engage patients and others in drug development and regulatory decision-making.

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.