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Regulatory Review Period for Vumerity

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alkermes Vumerity (diroxime...

EUA Revoked on Veklury After sNDA Approved

[ Price : $8.95]

Federal Register notice: FDA revokes the Emergency Use Authorization issued to Gilead Sciences for Veklury (remdesivir) for treati...

Avadel Sues FDA Over Lumryz NDA Delay

[ Price : $8.95]

Avadel sues FDA over the agencys decision to require a patent statement for the companys Lumryz NDA.

Develop Regulatory Framework for Synthetic Cells: Paper

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A Stat News opinion column argues the need for FDA and those working on synthetic cell therapies to open talks on an appropriate r...

FDA Accepts Biogen Tofersen NDA for Rare ALS

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FDA accepts a Biogen NDA for tofersen to treat a rare form of ALS and grants it priority review.

FDA Grants Taiho Oncology Lonsurf Petition

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FDA grants a Taiho petition restricting generic forms of its Lonsurf cancer drug.

Many Supplements Stay on Market After FDA Warning

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Researchers say FDA needs to strengthen enforcement against dietary supplements that contain prohibited ingredients.

Northeast Scientific 510(k) for Reprocessing Laser Catheter

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FDA clears a Northeast Scientific 510(k) for reprocessing Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, ...

Biotronik Pulsar-18 T3 Stent Approved

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FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation ...

Antibacterial Therapy Guidance Comments

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Two drug companies comment on an FDA draft guidance on antibacterial therapies.