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Info Collection Extension for Dear Doctor Letters

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for the guidance on dear doctor letters.

AbbVies Humira Follow-on Approved for Arthritis

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FDA approves AbbVies Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbust...

Heart Valves Get Expanded Indication

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FDA approves an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis w...

Panel to Discuss GSK NDA for OTC Nicotine Spray

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Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotin...

Nonclinical Osteoporosis Drug Study Guide

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Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies.

FDA/EMA Study Examines Drug Approval Concordance

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A new study shows that FDA and European Medicines Agency reviewers have a high concordance (9198%) in approving/rejecting new drug...

FDA OKs Harmony Bio New Narcolepsy Drug

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FDA approves a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with nar...

Comments Sought on Benefit/Risk Communications

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The Medical Device Innovation Consortium, of which FDA is a part, says it is soliciting public comments on a white paper on best p...

Genentechs Rozlytrek Approved for 2 Cancer Indications

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FDA grants accelerated approval for Genentechs Rozlytrek (entrectinib) for treating cancers in patients having the specific geneti...

Osteoporosis Drug Evaluation Guidance

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FDA issues a guidance to help drug sponsors design nonclinical bone studies to support approval of drugs and biologics intended to...