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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 09, 2022
Regulators need additional time to review information on bone mineral density. The FDA has provided a new PDUFA date of Aug. 6, 2022.
The move to limit Janssen’s vaccine comes after an analysis finds there is a risk of thrombocytopenia syndrome (TTS), a rare syndrome of blood clots and low levels of blood platelets.
May 06, 2022
The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.
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.