VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA 4 Modules Have Now Been Submitted, Reviewed, and Approved by the FDA Company on Track to File the 5th ...

MESQUITE, NV, Oct. 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process ...

The FDA issued another complete response letter for odronextamab for the treatment of relapsed/refractory follicular lymphoma.

The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

ApoE ε4 Carrier Status and Risk of ARIA Of the patients taking LEQEMBI, 16% (141/898) were ApoE ε4 homozygotes, 53% (479/898) were heterozygotes, and 31% (278/898) were noncarriers.

On December 30th NRXP announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA).

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not ...

Dyne Therapeutics Inc (NASDAQ:DYN) stock climbed 3.6% following the announcement that the U.S. Food and Drug Administration ...

The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee Act date of Jan. 28, 2026, according to a press release from Tenpoint ...

The company’s FDA-approved first generic sertraline capsules secured a 180‑day exclusivity period, highlighting strategic generic development pathways.