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Provention Bio Plans Rolling BLA for 2020

[ Price : $8.95]

Provention Bio says it is planning a rolling BLA application for its Type 1 diabetes drug teplizumab in 2020.

Draft Pediatric Oncology Studies Guidance

[ Price : $8.95]

FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...

Briviact Injection/Solution Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact oral solution ...

Cochlear Osia 2 Hearing Implant Cleared

[ Price : $8.95]

FDA clears a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant.

Vivitrol Ad Omits Risk Information: OPDP

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion warns Alkermes about a misleading Vivitrol print ad that omits important risk infor...

Xolair sBLA for Treating Nasal Polyps

[ Price : $8.95]

FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not ...

OTC Drug Reform Passes Senate

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The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.

Panel Rejects Correvios Vernakalant Over Safety

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FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for...

Sozo Cleared for Assessing Protein Calorie Malnutrition

[ Price : $8.95]

FDA clears an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition.

Courts Could See FDA Warning Letter as Final Action

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Attorney Michelle Yeary says a DC federal court decision might open the way for FDA Warning Letters to be considered final agency ...