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Roche Companion Diagnostic for AbbVies Emrelis OKd

[ Price : $8.95]

FDA approves Roches Ventana MET (SP44) RxDx Assay, a companion diagnostic to aid in determining MET protein expression in lung can...

Nipro Renal Recalls MedicaLyte Hemodialysis Product

[ Price : $8.95]

Nipro Renal Soultions recalls (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate due to the potential for the presence of vis...

Agency Has Evolved in the Last 10 Years: Verdun

[ Price : $8.95]

CBERs Nicole Verdun tells a Friends of Cancer Research meeting on next-generation therapies that FDA has evolved in the last decad...

Makary Says Vaccine Framework Coming Soon

[ Price : $8.95]

FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help wi...

Malaysias BioAsia Worldwide CGMP Issues

[ Price : $8.95]

FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as...

Cytokinetics Reports Exercise Data on Heart Drug

[ Price : $8.95]

Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exerc...

Hunter Syndrome Gene Therapy Accepted for Review

[ Price : $8.95]

FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) f...

CGMP Violations at Chinas Shantou S.E.Z. Baojie

[ Price : $8.95]

FDA warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be re...

FDA Doubts May Move Trials Overseas: Report

[ Price : $8.95]

Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instab...

FDA OKs First Oral Therapy for Rare Adrenal Tumors

[ Price : $8.95]

FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with ...