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© 2022 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2022 MJH Life Sciences™ and Formulary Watch. All rights reserved.
May 05, 2022
The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.
May 03, 2022
The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.
Orphalan plans to launch Cuvrior in early 2023. It was approved to treat Wilson’s disease, which results in excess copper in the body.
The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
May 02, 2022
The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.
Qelbree is the first new nonstimulant to be approved in 20 years.
The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.
April 30, 2022
The FDA’s Vaccines and Related Biological Products Advisory Committee has scheduled a meeting on June 7, 2022.
April 29, 2022
The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.
Moderna is also studying booster doses of the COVID-19 vaccine for all pediatric cohorts.