International Medical Assistance

December 23, 2020

December 23, 2020 – The U.S. FDA has approved Gemtesa® (vibegron), manufactured by Urovant Sciences, to treat overactive bladder (OAB) with symptoms of urge urinary incontinence
December 22, 2020

COVID19 Vaccines and other Regulatory Highlights

In December 2020, the U.S. FDA granted Emergency Use Authorization to Pfizer/BioNTech and Moderna for vaccines to prevent COVID-19 caused by SARS-CoV-2 infection. Moderna’s vaccine is indicated for use in individuals 18 and up
December 22, 2020

Vaxchora Indication Expanded to Include Children

December 22, 2020 – The U.S. FDA has approved an expanded indication for Vaxchora® (cholera vaccine, live) oral suspension, manufactured by Emergent Travel Health. The vaccine, which
December 21, 2020

Indications Expanded for Three Cystic Fibrosis Drugs

December 21, 2020 – The U.S. FDA has approved expanded indications for three medications from Vertex Pharmaceuticals that are indicated to treat cystic fibrosis (CF), with patients selected
December 14, 2020

Shorter Infusion Time Approved for Ocrevus

December 14, 2020 – The U.S. FDA has approved an additional, shorter infusion time for Ocrevus® (ocrelizumab). Manufactured by Roche, the drug is indicated to treat adults who have