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2 Antisense Oligonucleotide Drug Guidances

[ Price : $8.95]

FDA issues draft guidances with clinical recommendations and chemistry, manufacturing, and controls recommendations for sponsors d...

Products Association Sues FDA Over NAC

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The Natural Products Association says it is suing to force FDA to stop regulating N-acetyl-L-cysteine.

No FDA OK in Effect for Induction Therapies Product

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FDA warns Induction Therapies about marketing its Collagen P.I.N. microneedling product without agency approval.

Califf Nomination Heads to Senate HELP Hearing

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The Senate Health, Education, Labor & Pensions Committee announces a 12/14 hearing on the nomination of Robert Califf to be the ne...

FDA Inspections Will Adapt to New Strategies: Attorneys

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A Kleinfeld, Kaplan & Becker online post predicts that the prolonged Covid-19 pandemic will likely see the agency continue to adap...

FDA Reviewers Doubt Reata Kidney Drugs Effectiveness

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Ahead of a 12/8 FDA advisory committee meeting, agency reviewers cast doubt on the effectiveness of Reata Pharmaceuticals bardoxol...

Theratechnologies sBLA for HIV Drug Administration

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Theratechnologies files a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous push form of administration for treat...

Mammography Panel Seeks Nonvoting Reps

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Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...

JAK Inhibitors Implement FDA Class Warning

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An FDA-ordered drug class warning begins appearing in labels of Janus kinase (JAK) inhibitors Pfizers Xeljanz (tofacitinib), Eli ...

RefleXion Breakthrough for Radiotherapy

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FDA grants RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors...