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Merck Halts Keytruda Lung Cancer Trial

[ Price : $8.95]

Merck stops a Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynp...

Regulatory Review Determination for Truseltiq

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Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for QED Therapeutics Truse...

Pro Publica Slams FDA on Respirator Recall

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ProPublica and the Pittsburgh Post-Gazette take aim at alleged FDA failures to properly manage a timely response to reports of pro...

Section 503B Compounding Enforcement Discretion

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FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug...

FDA Clears BD Novel Blood Sampler

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FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fi...

Bill to Establish HHS Generic Drug Manufacturer

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Sen. Elizabeth Warren and Rep. Jan Schakowsky reintroduce their bill to establish a generic drug manufacturing operation within HH...

Review Extended on Sinus Drug

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FDA extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chro...

FDA Sets Bulk Substance Compounding Policy

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FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develop...

FDA Grants, Denies Provepharm ProvayBlue Petition

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FDA grants one provision in a Provepharm petition asking for restrictions on the approval of ANDAs or NDAs citing ProvayBlue as th...

Novartis Fabhalta for PNH Approved

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FDA approves Novartis Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria.