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May 06, 2022
Bortezomib is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program
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.
Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.
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.
