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New Drug Applications

DUBLIN, Ireland and CHICAGO, April 29, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutic...
Clinical Trial Results

Achieve Life Sciences, Inc. (Nasdaq ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisin...
New Drug Approvals

DEERFIELD, Ill. - 2024-05-13 -- Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an...
Clinical Trial Results

AUSTIN, Texas, May 14, 2024. Genprex, Inc. ( Genprex or the Company ), a clinical-stage gene therapy company focused on developing life-changing th...
New Drug Applications

COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration...
FDA Daily Update

Adding a chapter to the prolonged, back-and-forth legal battle involving recalled continuous positive air pressure (CPAP) machines, Philips Respiro...
FDA Daily Update

Sandoz is withdrawing from the UK’s Prescription Medicines Code of Practice Authority (PMCPA) after being dinged for promotional wording of its bio...
FDA Daily Update

Philips Respironics has recalled all Trilogy Evo ventilators that are not on the latest software update (1.05.06.00) due a software issue that can ...
FDA Daily Update

Cue Health must immediately stop sale and distribution of its COVID-19 tests and consumers should throw away any of the tests they may still have, ...
Drugs FDA Alerts

Audience: Health Care Provider, Consumer May 13, 2024 -- The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and he...
Clinical Trial Results

Merck (NYSE MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab c...
Clinical Trial Results

SHANGHAI, May 13, 2024, Mabwell, an innovation-driven biopharmaceutical company with entire industry chain, announced the progress of the clinical ...