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PTC Trial in ALS Patients Misses Endpoint

[ Price : $8.95]

PTC Therapeutics says its utreloxastat failed to meet the primary endpoint in a Phase 2 ALS study and development will not continu...

FDA Alert on Skysona Hematologic Malignancies

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FDA issues an alert about serious adverse event reports associated with Bluebird Bios Skysona (elivaldogene autotemcel), a gene th...

Soleno NDA Review Extended by 3 Months

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FDA extends by three months its review of a Soleno Therapeutics NDA for DCCR (diazoxide choline) extended-release tablets for trea...

Device Sterilization Enforcement Discretion Guide

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Federal Register notice: FDA makes available a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Steriliz...

Let FDA Set AI Postmarket Standards: Califf

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FDA commissioner Robert Califf asks Congress to give the agency the authority to set standards for postmarket evaluation of artifi...

Multiple Adept Medical Violations Cited

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FDA warns Auckland, New Zealand-based Adept Medical about Quality System and other violations in its production of ventilation tub...

CGMP Violations at Italys Eurosirel

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FDA warns Milan, Italy-based Eurosirel about CGMP violations in its production of finished drugs.

Oncologic Drugs Ovarian Toxicity Guidance

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FDA publishes a draft guidance with recommendations to oncologic drug sponsors about measuring ovarian toxicity in relevant clinic...

Court Tosses Attorneys Privacy Suit Against FDA

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The DC federal court agrees with FDA that a suit against the agency over identifying an attorney in a regulated company on a form ...

Satsuma Pharma NDA Resubmission for Migraine Drug

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FDA accepts for review a Satsuma Pharmaceuticals NDA resubmission for STS101 (dihydroergotamine nasal powder) for the acute treatm...