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Onpattros Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals Onp...

Byondis BLA on Breast Cancer Therapy Rejected

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FDA issues Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER...

Supreme Court Turns Down Skinny Label Case

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The U.S. Supreme court decides to not hear a closely watched appeal of a lower courts ruling in a so-called skinny label case won ...

Panel Backs Epinephrine Nasal Spray

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FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray...

Final Withdrawal Decision on Makena Published

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Federal Register notice: FDA publishes its final decision rendered last month to withdraw approval of Covis Pharma Groups Makena (...

Guide on Blood Product Donor Eligibility

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Federal Register notice: FDA makes available a final guidance entitled Recommendations for Evaluating Donor Eligibility Using Indi...

18 Drugs Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or e...

Orphan Status for Pyxis Pancreatic Cancer Therapy

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FDA grants Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer.

Cordis Class 1 Recall of Angioguard System

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Rated Class 1 by FDA, Cordis recalls its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns.

Congress Urges More FDA Attention to Rare Diseases

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A bipartisan group of U.S. Senators and House members call on FDA to step up its regulatory activities to improve rare disease pro...