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Asensus Surgical Articulating Instruments Cleared

[ Price : $8.95]

FDA clears an Asensus Surgical 510(k) for its 5 mm diameter articulating instruments for use on the Senhance Surgical System techn...

FDA Says Pepaxto Trial Found Increased Death Risk

[ Price : $8.95]

FDA says a required post-accelerated approval trial of Oncopeptides Pepaxto found an increased risk of death.

User Fee Rates for Drug Compounding Facilities

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Federal Register notice: FDA announces the fiscal year 2022 user fee rates for the establishment and reinspection fees related to ...

Priority NDA for Mycovias Yeast Infection Drug

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FDA accepts for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating chronic yeast ...

Another FDA Advisor Blasts Aduhelm Approval

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FDA advisory committee member G. Caleb Alexander lists the several ways he believes the agency erred in its accelerated approval o...

FDA OKs Synchron Stentrode IDE

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FDA approves a Synchron IDE for its Stentrode motor neuroprosthesis.

Gene Therapy for ALS Get Fast Track Status

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FDA grants Apic Bio a fast track designation for APB-102, a gene therapy candidate designed to treat SOD1 amyotrophic lateral scle...

Draft Guide on Olodaterol HCl; Tiotropium Bromide

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Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bro...

Regeneron, AstraZeneca Collaborate on Obesity

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Regeneron Pharmaceuticals and AstraZeneca enter into a collaboration to research, develop and commercialize small molecule compoun...

FDA Safety Assessment, Reporting Guidance Analyzed

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King & Spalding attorneys analyze an FDA draft guidance on safety event analysis and reporting in IND and BE/BA studies.