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16% Oncology Phase 2 Patients Get Drugs Later OKd

[ Price : $8.95]

Canadian researchers find that 16% of patients in Phase 2 oncology trials receive treatments that are later approved by FDA for th...

Abanza WasherCap Mini Fixation Device Cleared

[ Price : $8.95]

FDA clears an Abanza 510(k) for its WasherCap Mini fixation system for soft tissue repair, including meniscal root repair and ante...

Regeneron Refiles BLA for Follicular Lymphoma

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FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory follicular lymphoma.

Generic Mifepristone Maker Wants to Defend Suit

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GenBioPro, which manufactures FDA-approved generic mifepristone, says it wants to be added to the list of defendants in a suit see...

More FDA Cuts Coming Down the Road

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Fresh on the heels of staff disruptions caused by the termination of about 1,000 probationary employees, the Trump administration ...

Fertility Center of California HCT/P Deviations

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FDA warns San Diego, CA-based Fertility Center of California about deviations from regulations governing cells, tissues, and cellu...

Priority Review for Keytruda Head/Neck Cancer sBLA

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locall...

FDA Removes Clozapine REMS Program

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FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of ab...

4 Observations on AstraZeneca FDA-483

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FDA releases the form FDA-483 issued following an inspection at the AstraZeneca Frederick, MD, drug manufacturing facility.

Emalex Ecopipam Meets Tourette Study Endpoints

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Emalex Biosciences says it will meet with FDA to discuss submitting an NDA for its ecopipam to treat Tourette syndrome following s...