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House Passes Drug Pricing Bill

[ Price : $8.95]

The House approves drug pricing legislation that is likely to die in the Senate or face a presidential veto.

Provention Bio Plans Rolling BLA for 2020

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

Draft Pediatric Oncology Studies Guidance

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FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...

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 ...

CRN Praises Court Decision in Fish Oil Case

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The Council for Responsible Nutrition praises the Supreme Courts refusal to hear an Amrin appeal of a fish oil dietary supplement ...

Briviact Injection/Solution Regulatory Review Period

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

Cochlear Osia 2 Hearing Implant Cleared

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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

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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

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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.