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Baxter Recalls AK 98 Dialysis Machines

[ Price : $8.95]

Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposur...

Circulating Tumor DNA Use Guidance

[ Price : $8.95]

FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.

Patheon Italia FDA-483 Out

[ Price : $8.95]

FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug ...

Follow-up Testing for Ames-Positive Drugs Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Ac...

Guide on Assessing Ovarian Toxicity

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults Duri...

Oncologic Drugs Advisory Committee Renewal

[ Price : $8.95]

Federal Register notice: FDA renews its Oncologic Drugs Advisory Committee for an additional two years.

8 GDUFA Science and Research Priorities

[ Price : $8.95]

FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.

PTC Trial in ALS Patients Misses Endpoint

[ Price : $8.95]

PTC Therapeutics says its utreloxastat failed to meet the primary endpoint in a Phase 2 ALS study and development will not continu...

FDA Alert on Skysona Hematologic Malignancies

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FDA issues an alert about serious adverse event reports associated with Bluebird Bios Skysona (elivaldogene autotemcel), a gene th...

Soleno NDA Review Extended by 3 Months

[ Price : $8.95]

FDA extends by three months its review of a Soleno Therapeutics NDA for DCCR (diazoxide choline) extended-release tablets for trea...