Submission

Seeking approval for Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP)NDA eligible for Priority Review Ad hoc announcement pursuant…

CLEVELAND, July 28, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company’s…

Submission based on five Phase III clinical trials, including overwhelmingly positive results from the -33 Phase 3 studyAn estimated one in three adults will suffer motion sickness at some point1 ST. LOUIS, July 26, 2023 (GLOBE…

Madrigal expects to complete full submission of the New Drug Application in July 2023 CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing…

June 29, 2023News release BioPorto Announces Submission of Response to FDA Additional Information Letter COPENHAGEN, DENMARK and BOSTON, MA, June 29, 2023, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto or Company) (CPH:BIOPOR) today…

Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few treatment options currently available…

Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few treatment options currently available…

Combination Creates Clear Pure-Play Additive Manufacturing Leader with Unmatched Scale and Highly Attractive Financial Profile in Rapidly Scaling IndustrySignificant Shareholder Value Creation Fueled by $100 Million of Cost…

TOKYO and CAMBRIDGE, Mass., May 15, 2023 (GLOBE NEWSWIRE) --…

TORONTO, Ontario and CAMBRIDGE, Massachusetts, April 10, 2023…