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Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust

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A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory co...

Full Approval Given to Lilly's Retevmo

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FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pe...

CGMP Issues Found at International Medication Systems

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FDA warns South El Monte, CA-based International Medication Systems about CGMP violations in its production of finished drugs.

Multiple Violations in ZIIP Inspection

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FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adulterated and misbranded unappr...

Biogen Defends Anti-Tau Alzheimer's Data After Investor Selloff

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Biogen executives attempt to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promi...

DTC Advertising Industry Braces for Potential End of Adequate Provision

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DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provision standard could amount to ...

Ascelia Clarifies CRL on MRI Agent After Public Release

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Ascelia Pharma pushes back against FDA's recent public release of a Complete Response Letter for its MRI contrast agent Orviglance...

GSKs Jemperli Trial Meets Endpoint in Rectal Cancer

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GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients wit...

Draft Guidance Outlines Development Standards for Psychedelic Drugs

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FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors w...

FDA Approves At-Home Dosing of Leqembi for Alzheimer's

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FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients...