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ProJenX Partial Hold Lifted in ALS Study

[ Price : $8.95]

FDA removes a partial clinical hold against ProJenX and its Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin in ...

Roche Cobas Malaria Test Approved

[ Price : $8.95]

FDA approves Roches cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potentia...

Poll Backs FDA Status Quo in Approving Products

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In the wake of this weeks U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that m...

Guidance on IND Safety Report eSubmissions

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FDA releases a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports.

Review Extended on Govorestat NDA

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FDA extends by three months its review of an Applied Therapeutics NDA for govorestat (AT-007) for treating classic galactosemia.

Dental Bone Graft Animal Study Guide

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FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).

FDA Approves Akebia Vafseo for Some Anemias

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FDA approves Akeibas Vafseo to treat anemia in some adults with chronic kidney disease.

Aldeyra Plans for Reproxalap NDA Resubmission

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Aldeyra Therapeutics says it will conduct a dry eye chamber clinical trial of its reproxalap in hopes of resubmitting an NDA for t...

3-year-old Fusion IV FDA-483 Released

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FDA releases the form FDA-483 that was issued following a 2019 inspection at the Fusion IV outsourcing facility in Los Angeles, CA...

ASCA Pilot Met, Exceeded Expectations: CDRH

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The CDRH Accreditation Scheme for Conformity Assessment pilot final report says the effort met and sometimes exceeded agency expec...