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Latest From Marinus Pharmaceuticals, Inc.
EMA Backs EU Approval For Ztalmy & Pylclari Roche Withdraws EU Filing For AMD Implant
Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.
EMA: Marinus Filing Up For An Opinion; Amylyx, GSK & Curium Due For Oral Explanations
The European Medicines Agency’s human medicines committee, the CHMP, is meeting this week to discuss the EU marketing applications for a number of products that have reached the late stages of the regulatory review cycle.
FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022
Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
Generics And Biosimilars Industry Reshaped By Transformations
The latest Generics Bulletin Top 50 ranking of global generics and biosimilars companies sees a new name in the top five amid transformations for some of the leading off-patent players. Meanwhile, a number of mid-level firms shift position and newcomers climb into the bottom of the table.
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