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X4 Pharm NDA for WHIM Syndrome

[ Price : $8.95]

X4 Pharmaceuticals files an NDA for a once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (warts, hypoga...

Primary Endpoint Met in Alecensa Study: Roche

[ Price : $8.95]

Roche says recent data from its Phase 3 ALINA study evaluating Alecensa (alectinib) compared with platinum-based chemotherapy met ...

Guide on Mycobacterial Pulmonary Disease

[ Price : $8.95]

FDA posts a final guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex (MAC): De...

Generic Post-Warning Letter Meetings Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA that provides information on implementing the new pro...

Guide on Drug Wholesaler Enforcement

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance to describe that enforcement policies will be extended for an additional y...

More Variants Cleared for 23andMe Genetic Test

[ Price : $8.95]

FDA clears a 23andMe 510(k) to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report by allowing it to re...

Universal Meditech Recalls All Test Products

[ Price : $8.95]

FDA says Universal Meditech has recalled all test products manufactured between 3/2021 and 11/2022 because the company is ceasing ...

Hugel Refiles BLA Addressing FDA Concerns

[ Price : $8.95]

Korea-based Hugel resubmits its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown)...

Sage Reorganizing to Support Zurzuave Launch

[ Price : $8.95]

Sage Therapeutics says it is downsizing and reorganizing to prepare for the launch of its postpartum depression drug Zurzuave late...

BD Suggestions for Microbiology Panel

[ Price : $8.95]

Becton Dickinson asks the FDA Microbiology Devices Panel to consider four points at its 9/8 discussion of diagnostic devices in fu...