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Merck, Eisai Stop LEAP-010 Trial

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Merck and Eisai terminate the Phase 3 LEAP-010 trial evaluating Mercks Keytruda (pembrolizumab) plus Eisais Lenvima (lenvatinib) i...

Finalized Informed Consent Guidance Analyzed

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Ropes & Gray attorneys break down a new FDA final guidance on informed consent, highlighting changes from a previous draft.

FDA OKs New Veklury Covid Indication

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FDA approves a Gilead Veklury sNDA eliminating the need for dose adjustments when treating Covid-19 in patients with mild, moderat...

Akebia Plans 3rd Quarter Vadadustat NDA Resubmission

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Akebia Therapeutics says it plans to resubmit an NDA to FDA for vadadustat to treat anemia due to chronic kidney disease.

Fast Track for Abdominal Aneurysm Product

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FDA grants Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment combination product for ...

Paragonix Donor Lung Preservation Device Cleared

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FDA clears a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard.

More Drug Approval Transparency Needed: Studies

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Oregon State University says two research studies show that more drug approval transparency is needed.

Panel to Mull 2024 Flu Vaccine Strain

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Federal Register notice: FDA announces a 10/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss the 2...

FDA Gives Fast Track to Rett Gene Therapy

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FDA grants Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for ...

FDA Approves 1st Tysabri Biosimilar

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FDA approves a Sandoz BLA for Tyruko (natalizumab-sztn), the first biosimilar to Biogens Tysabri (natalizumab) injection for treat...