Author | Jenna Payesko

Articles

FDA Rejects Duchenne Muscular Dystrophy Drug Golodirsen, Citing Safety Concerns

August 23, 2019

The regulatory agency cited 2 concerns in the complete response letter: the risk of infections related to intravenous infusion ports and renal toxicity.

FDA Rejects Duchenne Muscular Dystrophy Drug Golodirsen, Citing Safety Concerns

August 20, 2019

The regulatory agency cited 2 concerns in the complete response letter: the risk of infections related to intravenous infusion ports and renal toxicity.

Pfizer Recalls Relpax for Migraine Due to Potential Microbiological Contamination

August 20, 2019

Those with an existing inventory of eletriptan hydrobromide 40 mg tablets, lots AR5407 and CD4565, should stop use and distribution, and quarantine immediately.

Phase 3 Trial of Vutrisiran Evaluates Potential Therapy for Hereditary Transthyretin-Mediated Amyloidosis

August 19, 2019

The investigational candidate is the subject of a phase 3 study assessing efficacy and safety in adults with hATTR amyloidosis with transthyretin mutation.