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April 5, 2021

FDA Clears Nonstimulant for ADHD in Kids 6 Years and Up FDA Clears Nonstimulant for ADHD in Kids 6 Years and Up

The US Food and Drug Administration (FDA) has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder […]
April 1, 2021

FDA Okays New Indication for Alirocumab in Homozygous FH FDA Okays New Indication for Alirocumab in Homozygous FH

The US Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced. The proprotein convertase […]
March 31, 2021

Europe Approves Pemigatinib for Bile Duct Cancer Europe Approves Pemigatinib for Bile Duct Cancer

The European Commission has approved the oral targeted therapy pemigatinib (Pemazyre) for the treatment of locally advanced or metastatic cholangiocarcinoma, a rare cancer of the bile […]
March 29, 2021

EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma

European Union approval has been recommended for duvelisib (Copiktra) for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or refractory follicular lymphoma (FL) who have received at […]
March 29, 2021

First CAR T-Cell Therapy for Multiple Myeloma: Abecma First CAR T-Cell Therapy for Multiple Myeloma: Abecma

Chimeric antigen receptor (CAR) T-cell therapy, described as a “living drug,” is now available for patients with relapsed/refractory multiple myeloma who have been treated with four […]
March 26, 2021

FDA OKs Transcatheter Pulmonary Valve for Congenital Heart Disease FDA OKs Transcatheter Pulmonary Valve for Congenital Heart Disease

The US Food and Drug Administration (FDA) has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System to treat severe pulmonary regurgitation in pediatric and adult patients […]
March 26, 2021

FDA OKs Neuromodulation Device to Improve Gait in MS FDA OKs Neuromodulation Device to Improve Gait in MS

The US Food and Drug Administration (FDA) has approved the Portable Neuromodulation Stimulator (PoNS, Helius Medical Inc) for the short-term treatment of walking impairments as a […]
March 25, 2021

Abuse of OTC Decongestant Potentially Deadly, FDA Warns Abuse of OTC Decongestant Potentially Deadly, FDA Warns

Abuse or misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can cause serious harm that can lead to hospitalization, disability, or death, the US Food and […]
March 24, 2021

Class I Recall Issued for Some Affinity Pixie Oxygenators Class I Recall Issued for Some Affinity Pixie Oxygenators

Medtronic is recalling some Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface devices and Perfusion Tubing Packs because of potentially elevated levels of bacterial […]
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