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FDA Daily Update

The 2023 annual survey of members of Team NB, The European Association Medical Devices — Notified Bodies, shows a steady increase in both applicati...
FDA Daily Update

Sen. Bernie Sanders (I-Vt.) has raised his battle flag against high drug prices on a crumbling hill, according to a conservative think tank that’s ...
FDA Daily Update

Dynavax announced it received an FDA complete response letter (CRL) on its sBLA for Heplisav-B vaccine because the third-party clinical trial site ...
FDA Daily Update

If CDRH doesn't get $11.5 million from Congress this year to keep up its program to prevent medical device supply chain disruptions, the program wi...
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 ...