The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Source link: [link].

Medicine 52

Medicine Generic Pharmaceutical FDA Approval Packaging 52

The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. Recently, US Food and Drug Administration (FDA) also approved the citrate-free HCF of Hyrimoz ® (adalimumab-adaz) injection.

Medicine 40

Medicine Generic Pharmaceutical FDA Approval Marketing 40

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98