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FDA Approves Unloxcyt (cosibelimab-ipdl) for the Treatment of Cutaneous Squamous Cell Carcinoma

drugs.com - 13/Dec 21:12

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), today announced that the U.S. Food and...

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uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease

drugs.com - 10/Dec 01:12

LEXINGTON, Mass. and AMSTERDAM, Dec. 10, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative...

FDA pre-approval inspection of EBR’s WiSE CRT system set for early January

stockhead.com.au - 19/Dec 22:55

The US FDA has scheduled a pre-approval inspection of EBR System’s WiSE CRT System for the week of January 6, ...

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QURE Soars on FDA Alignment for Speedy Approval of Huntington's Drug

zacks.com - 11/Dec 15:02

uniQure stock rallies 110% on reaching alignment with the FDA on key elements of an accelerated approval pathway for AMT-130 to treat Huntington's...

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Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP)

drugs.com - 19/Dec 01:12

TARRYTOWN, N.Y., December 19, 2024 – Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and...

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Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP)

drugs.com - 19/Dec 01:12

TARRYTOWN, N.Y., December 19, 2024 – Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and...

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MBOT Stock Gains Following FDA Submission of the LIBERTY System

zacks.com - 12/Dec 16:51

Microbot Medical announces the submission of its LIBERTY System for FDA marketing clearance.

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FDA Approved Drug Products Approval List November 2024

pharmabiz.com - 18/Dec 12:18

FDA Approved Drug Products Approval List November 2024

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ZBH Stock Might Rise Following FDA Nod for OsseoFit

zacks.com - 16/Dec 12:35

Zimmer Biomet's OsseoFit Stemless Shoulder System gets FDA 510(k) approval. The company expects to launch the system in the first quarter of 2025.