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Records Updated to Reflect EUAs for 2 Biologics

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Federal Register notice: FDA updates its administrative records to reflect two Emergency Use Authorizations for biological product...

FDA Restricts Ocaliva Use in Some PBC Patients

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FDA says it is restricting the use of Intercepts Ocaliva in patients with primary biliary cholangitis and advanced cirrhosis of th...

FDA Reverses Trump HHS Unapproved Drug Initiative Notice

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In a sharply worded notice, FDA acting commissioner Janet Woodcock says the agency is reversing a Trump administration HHS notice ...

FDA Clinical Hold on Larimar CTI-1601

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FDA puts a clinical hold on the Larimar Therapeutics clinical development program for CTI-1601 to treat Friedreichs ataxia.

FDA May Decline Covid-19 EUA Requests

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FDA updates its guidance on Covid-19 EUAs to reflect that it may decline to review and process further EUA requests other than tho...

More Data Needed for Travere Accelerated NDA: FDA

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FDA tells Travere Therapeutics that data from the ongoing Phase 3 DUPLEX study of sparsentan for treating focal segmental glomerul...

FDA Denies Vifor Fresenius Velphoro Petition

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FDA denies a Vifor Fresenius request for five-year NCE exclusivity for its Velphoro.

FDA Warns 5 Companies Over Infertility Treatments

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FDA and the FTC warn five companies they are marketing unapproved new drugs as dietary supplements to treat infertility.

FDA Approves Myfembree for Heavy Menstrual Bleeding

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FDA approves a Myovant Sciences and Pfizer NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) f...

Biotek India CGMP Violations

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FDA warns Biotek India about CGMP violations in its manufacturing of OTC drugs and its marketing of a misbranded unapproved new OT...