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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

Germany Sanctions Novartis’ Cell Culture-Based H1N1 Flu Vaccine

Regulatory

EU Clears Avastin as Combo Therapy for Recurrent Ovarian Cancer

Regulatory

Orexo Receives FDA Green Light for Insomnia Drug

Regulatory

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

Regulatory

Redx Halts Enrollment in Trial of Lead Candidate, Citing Adverse Events

Regulatory

FDA Gives Abbott a Thumbs-Up for Automated HBV Monitoring Test

Regulatory

Dendreon Gets Green Light in Europe

Overall consensus of agency and CDER was that drug's benefits do not outweigh the risks. [© robert mobley - Fotolia.com]

Regulatory

After Panel’s Vote, Fate of Avastin for MBC in U.S. Rests...

Regulatory

EU Sanctions Novartis Drug for Steroid-Induced Osteoporosis

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