GlobalReach Health – Page 51 – Global Reach Health

July 20, 2021

First FDA-Approved Medication for Rare Liver Disorder Launched

July 20, 2021 – Albireo Pharma’s Bylvay^TM (odevixibat) has become the first drug approved by the U.S. FDA to treat pruritus in individuals who are at least three months

July 20, 2021

Octagam Receives Indication for Rare Disease of the Muscle Tissues

July 20, 2021 – The U.S. FDA has approved a new indication for Octagam^® 10% [immune globulin intravenous (human)] to treat adult dermatomyositis, a rare inflammatory

July 16, 2021

Prograf Becomes First FDA-Approved Drug to Prevent Organ Rejection in Adult and Pediatric Lung Transplant Recipients

July 16, 2021 – The U.S. FDA has approved an expanded indication for Prograf^® (tacrolimus – Astellas Pharma)

July 16, 2021

FDA Approves First-in-Class Treatment for Chronic Graft-Versus-Host Disease

July 16, 2021 – The U.S. FDA has approved Rezurock^TM (belumosudil), manufactured by Kadmon Holdings, to treat chronic graft-versus-host

July 16, 2021

Vaxneuvance Approved to Prevent Pneumococcal Disease

July 16, 2021 – The U.S. FDA has approved Vaxneuvance^TM (pneumococcal 15-valent conjugate vaccine – Merck) for active immunization to prevent invasive disease

July 16, 2021

New Oral Treatment for Sleeping Sickness Approved

July 16, 2021 – The U.S. FDA has approved Sanofi’s fexinidazole tablets to treat both stages of sleeping sickness (human African trypanosomiasis, or HAT) caused by Trypanosoma

July 12, 2021

FDA Requires Expanded Black Box Warning for Hydroxyethyl Starch Products Used to Treat and Prevent Hypovolemia

July 12, 2021 – The U.S. FDA is requiring an expanded black box warning for hydroxyethyl

July 12, 2021

Darzalex Faspro Receives New Multiple Myeloma Indication

July 12, 2021 – The U.S. FDA has approved a new indication for Janssen’s Darzalex Faspro^® (daratumumab/ hyaluronidase-fihj) to be used in combination with pomalidomide