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FDA Daily Update

This week, the European Parliament adopted the European Commission’s (EC) proposal to grant more time for companies to come into compliance with 20...
FDA Daily Update

In this edition of Quick Notes, the FDA has elevated four device recalls to Class I, including an infusion pump that has caused six injuries and on...
FDA Daily Update

Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements...
FDA Daily Update

This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, rev...
FDA Daily Update

Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL pisto...
New Drug Approvals

April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncom...
New Drug Approvals

BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-sta...
Clinical Trial Results

In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening ...
FDA Daily Update

A Senate committee has demanded answers from Danish pharma Novo Nordisk on what it labels “astronomically” high prices for the company’s Ozempic/We...
FDA Daily Update

In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder...
FDA Daily Update

Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning L...
Clinical Trial Results

FORT MYERS, Fla., April 25, 2024. Florida Cancer Specialists Research Institute, LLC (FCS) medical oncologist and hematologist Ernesto Bustinza-Lin...