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Aquestive Will Resubmit Anophylm NDA in 3rd Quarter

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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...

FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

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Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella hea...

Ibrahim Appointed CDER Deputy Center Director

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FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capaci...

Trump Administration Weighs Executive Order on Autism, Vaccines

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The Trump administration considers an executive order addressing vaccines and autism as soon as next week.

Senators Introduce Prescription Information Modernization Act

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Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) introduce the bipartisan Prescription Information Modernization Act to allow dr...