Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qiagen, Spintech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Aprea, Immvira, Polpharma, Spectrum.
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease.
TORONTO – Health Canada has green-lighted an all-in-one virtual reality (VR) platform for use in diagnostic radiology. Software developer Luxsonic Technologies Inc. said the award of a class II medical device license to its mobile Sievrt suite of diagnostic tools is the first time a VR system of this kind has been approved by a national regulatory agency.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space.
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Certest Biotech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, China Pharma, Eiger, Everest, Exelixis, Merck, Therapeutic Solutions.
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