drug development

FDA Clears WIDAPLIK™, Developed with Piramal Pharma Solutions

Piramal Pharma Solutions, a global contract development and manufacturing organization (CDMO), has collaborated with George Medicines to develop WIDAPLIK™,...

By cGxPwire Editor
August 29, 2025

Bio-Pharma Pharma

Zydus Therapeutics Reports Positive Topline Results from EPICS-III Trial of Saroglitazar Magnesium in Primary Biliary Cholangitis

Zydus Therapeutics, Inc., a U.S.-based innovation arm of Zydus Lifesciences Ltd., today announced positive topline data from its pivotal...

By cGxPwire Editor
August 29, 2025

MedTech

Imbed Biosciences Gains FDA IDE for Silver-Gallium Wound Matrix Trial

Imbed Biosciences has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE)...

By cGxPwire Editor
August 28, 2025

.gov

FDA Approves Updated 2025–2026 COVID-19 Vaccines from Pfizer, Moderna, and Novavax

The FDA has approved updated COVID-19 vaccines from Pfizer/BioNTech, Moderna, and Novavax for the 2025-2026 season, targeting high-risk groups....

By cGxPwire Editor
August 27, 2025

.gov

FDA Ends Broad Emergency Authorization, Approves Updated COVID-19 Vaccines

The FDA approved updated COVID-19 vaccines from Pfizer/BioNTech, Moderna, and Novavax while ending broad Emergency Use Authorization. Eligibility is...

By cGxPwire Editor
August 27, 2025

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M&A

AbbVie Acquires Gilgamesh Pharmaceuticals’ Bretisilocin, A Novel Psychedelic Therapy for Major Depressive Disorder

AbbVie (NYSE: ABBV) has announced a definitive agreement to acquire Gilgamesh Pharmaceuticals’ lead investigational candidate bretisilocin (GM-2505), a next-generation...