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FDA Sets BsUFA Goal Date for Alvotechs Humira Biosimilar

[ Price : $8.95]

Icelands Alvotech says it expects an FDA decision on its BLA for a Humira biosimilar on 4/13.

Celltrion Submits BLA for Novel Infliximab Formula

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Celltrion USA submits a BLA to FDA for a novel subcutaneous formulation of its infliximab to be used as maintenance therapy in som...

Empowered Diagnostics Unapproved Covid Tests

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FDA warns Pompano Beach, FL-based Empowered Diagnostics about illegally manufacturing and distributing Covid-19 tests.

FDA Will Review Pfizer Etrasimod NDA

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FDA accepts for review a Pfizer NDA for etrasimod to treat some patients with ulcerative colitis.

Green Pharmaceuticals SnoreStop Adulterated: FDA

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FDA warns Camarillo, CA-based Green Pharmaceuticals that it is distributing an adulterated unapproved new drug.

Madrigals Resmetirom Hits Phase 3 NASH Endpoints

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Madrigal Pharmaceuticals says its resmetirom met FDA-suggested endpoints in the pivotal Phase 3 MAESTRO-NASH trial to treat nonalc...

Address Prescription Adderall Shortage: Spanberger

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Rep. Abigail Spanberger asks FDA and the DEA how they will work together and independently to overcome the current shortage of Add...

Academics Urge Tougher FDA Stance on Accelerated NDAs

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Two JAMA articles say FDA should seek to tweak its accelerated approval program to make it easier for it to pull an approval if a ...

Device Voluntary Malfunction Summary Reporting Guide

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Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manu...

Guide on Device Human Factors Submission Info

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Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Subm...