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FDA, Ultragenyx Settle OTC Phase 3 Study Design

[ Price : $8.95]

FDA and Ultragenyx reach an agreement on the design and endpoints for a Phase 3 study of the companys DTX301 ornithine transcarbam...

Workshop on Model Informed Drug Development

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Federal Register notice: FDA announces a 6/9 public workshop entitled Model Informed Drug Development Approaches for Immunogenicit...

EUA Listing for Covid Molecular/Antigen Tests

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Federal Register notice: FDA posts an updated listing of Emergency Use Authorizations for molecular diagnostic and antigen tests f...

Info Collection on Soy Protein Health Claim

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Federal Register notice: FDA sends to OMB an information collection extension entitled Record Retention Requirements for the Soy P...

FDA Clears SoundBite Crossing System

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FDA clears a Soundbite 510(k) for the SoundBite Crossing System Peripheral with an 0.014 Active Wire for treating peripheral arte...

Lilly/Incyte Plan sNDA for Baricitinib in Alopecia

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Eli Lilly and and Incyte plan to file a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a s...

Lexeo Fast Track for Alzheimers Therapy

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FDA grants Lexeo Therapeutics a fast track designation for LX1001, an adeno-associated virus mediated gene therapy for treating ap...

BD Recalls 30 Lots of ChloraPrep Hi-Lite Orange Applicator

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FDA says BD is recalling 30 lots of its ChloraPrep 26 mL applicator due to a defective applicator.

FDA Approves GSK Jemperli for Some Endometrial Cancers

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FDA grants accelerated approval to GlaxoSmithKlines Jemperli to treat some endometrial cancers in patients with a specific biomark...

FDA Clears Orthofix Forza Spacer System

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FDA grants 510(k) clearance to the Orthofix Forza titanium spacer system.