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Hamilton Medical Removes Breathing Circuit Set

[ Price : $8.95]

An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMIL...

Belite Bio Files NDA for Stargardt Disease

[ Price : $8.95]

FDA accepts for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1.

New Pathway Sought for Albuterol Inhalation Aerosol Products

[ Price : $8.95]

A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.

Veloxis Paying $46 Million to Resolve Kickback Charges

[ Price : $8.95]

The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company i...

Aquestive Will Resubmit Anophylm NDA in 3rd Quarter

[ Price : $8.95]

Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete ...

3 Observations in MSN Life Sciences Inspection

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FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceut...

NDA for PTSD Therapy Resubmitted

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Resilient Pharmaceuticals resubmits an NDA for its midomafetamine capsules for a proposed indication of treating post-traumatic st...

Trump Orders Changes to Childhood Vaccine Recommendations

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President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Chi...

Tenaxs TNX-103 Misses Primary Endpoint in Phase 3 Trial

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Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating ...

ITM Receives FDA Complete Response Letter for Radiopharmaceutical

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FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gast...