New drug application
FDA Denies Approval for Galera’s Oral Mucositis Drug
SG Tylor
The FDA has issued a complete response letter in response to the new drug application (NDA) for avasopasem manganese (GC4419), ...
FDA Approves Cyclophosphamide Injection NDA for Multiple Cancers
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Source – Nevakar Injectables On July 3, 2023 the FDA has approved a new drug application (NDA) for 200-mg/mL vials ...
Verona Pharma has recently filed a New Drug Application to FDA for the use of ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease
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Source – Verona Pharma On June 27, 2023, Verona Pharma announced the submission of a New Drug Application (NDA) to ...
FDA Prolongates PDUFA Nirogacestat’s NDA for desmoid tumors is three months
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Source – SpringWorks According to SpringWorks Therapeutics on June 7, 2023, the FDA has extended the Prescription Drug User Fee ...
