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Abivax Favorable Data in Ulcerative Colitis Trials

[ Price : $8.95]

Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimo...

Bill to Require Drug Price in DTC Ads

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Five House members introduce a bill to require DTC television ads to include the drugs list price.

Gilead Sciences Settlement Helps 49 States

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Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with Gilead Sciences to resolve cha...

Stakeholder Suggestions for PDUFA Reauthorization

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Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional funding and take steps to imp...

Medline Recalls Craniotomy Kits

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Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable P...

FDA Priority Review for Sprouts Addyi sNDA

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FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal wo...

FDA to Demand New Elevidys Safety Data from Sarepta

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FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the com...

RFK Jr. OKs Directive to Ban Thimerosal in Flu Shots

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HHS secretary Robert F. Kennedy, Jr. approves a new federal directive removing thimerosal, a mercury-based preservative, from all ...

FDA Soliciting CNPV Pilot Interest

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FDA solicits statements of interest in being one of no more than five drug and biologic developers to participate in the initial c...

Few ODAC Advisory Committee Questions Difficult: Study

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University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficu...