Biopharma, FDA and Pharmaceutical products

FDA Approves BioMarin Pharma’s Gene Therapy, the First for Hemophilia A

MedCity News

JUNE 29, 2023

The FDA approved Roctavian for treating hemophilia A. The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder.

FDA

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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

MedCity News

AUGUST 7, 2023

The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.

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AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease

MedCity News

JUNE 20, 2022

In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication. AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation.

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Pharma Rep Focus

FDA Approves BioMarin Pharma’s Gene Therapy, the First for Hemophilia A

Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease

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