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Industry Groups Fire Back as Trump Proposes Cutting Part B Medicare Drug Costs

Regulatory

Protalix’ Phase III Candidate for Gaucher’s May Fill the Treatment Gap due to Genzyme’s Plant Closure

Regulatory

Shire’s Gaucher Disease Drug Candidate Being Considered by FDA

$Agency had asked that an additional clinical study be conducted in relapsed/refractory aggressive NHL. [Andrew S. - Fotolia.com]$

Regulatory

Cell Therapeutics to Appeal FDA Decision on Pixantrone NDA

Regulatory

DNA Probe–Based Patch Offers Novel Approach to Detecting Food Contamination

Source: Sebastian Kaulitzki/Fotolia

Regulatory

Autism Risk Increased through Structural Variants Inherited from Dad

Regulatory

FDA Clears Archimedes’ Fentanyl Nasal Spray for Breakthrough Cancer Pain

Regulatory

Germany Sanctions Novartis’ Cell Culture-Based H1N1 Flu Vaccine

Regulatory

EMA Green-Lights Shire’s Manufacturing Site in Lexington, MA, for Gaucher Therapy

Regulatory

Orexo Receives FDA Green Light for Insomnia Drug

Regulatory

Amgen Sues to Reverse FDA Denial of Pediatric Exclusivity for Sensipar

Amgen and Novartis are set to commercially launch the migraine prevention treatment Aimovig™ (erenumab) in the U.S. next week—the first calcitonin gene-related peptide (CGRP) receptor inhibitor approved by the FDA.

Regulatory

Amgen, Novartis Set to Launch Migraine Drug Aimovig Next Week after...

Regulatory

GSK’s BPH Therapy Receives European Clearance

Regulatory

Dendreon Gets Green Light in Europe

Regulatory

Novel Treatment for Most Common Type of Lung Cancer

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