Global healthcare – Page 48 – Global Reach Health

August 6, 2021

New Enzyme Replacement Therapy Approved for Pompe Disease

August 6, 2021 – The U.S. FDA has approved Sanofi’s Nexviazyme^® (avalglucosidase alfa-ngpt), to treat late-onset Pompe disease (LOPD) in patients who are at least a year old.

August 6, 2021

Two Lots of Atovaquone Oral Suspension Recalled

August 6, 2021 – KVK Tech, Inc., has voluntarily recalled two lots of Atovaquone Oral Suspension, USP 750 mg/5mL, following customer complaints that the product was unusually gritty

August 2, 2021

Saphnelo Approved as First-in-Class Treatment for Lupus

August 2, 2021 – The U.S. FDA has approved Saphnelo^TM (anifrolumab-fnia), manufactured by AstraZeneca, to treat moderate to severe systemic lupus erythematosus (SLE) in adults who

July 30, 2021

July 30, 2021 – The U.S. FDA has updated emergency use authorization (EUA) for Regeneron’s REGEN- COV^TM (casirivimab and imdevimab). The monoclonal antibody

July 29, 2021

Changes Made to Risk Evaluation and Mitigation Strategy for Drug Approved to Treat Schizophrenia

July 29, 2021 – The U.S. FDA has approved changes to the Risk Evaluation and Mitigation Strategy (REMS) program

July 29, 2021

Nucala Receives New Nasal Polyps Indication

July 29, 2021 – Nucala^® (mepolizumab), manufactured by GlaxoSmithKline, has received U.S. FDA approval for a new indication to treat chronic rhinosinusitis with nasal polyps (CRSwNP)

July 28, 2021

Pepaxto Associated with Increased Risk of Death in a Clinical Trial

July 28, 2021 – Pepaxto^® (melphalan flufenamide – Oncopeptides AB) may increase the risk of death for patients who have multiple myeloma, according to the U.S. FDA. In 2021

July 28, 2021

Olumiant Authorized for Use Alone to Treat COVID-19 in Hospitalized Patients

July 28, 2021 – The U.S. FDA has expanded the scope of Emergency Use Authorization (EUA) for Olumiant (baricitinib – Eli Lilly) to allow