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Priority Voucher Used on Genentechs Vabysmo Approval

[ Price : $8.95]

Federal Register notice: FDA announces that a product was approved using a priority review voucher Genentechs Vabysmo (faricimab-...

CDER, CBER Accept 1st ISTAND Submission

[ Price : $8.95]

CDER and CBER accept the first letter of intent submission for the new Innovative Science and Technology Approaches for New Drugs ...

Ionis/AstraZeneca Planning NDA for Eplontersen

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After reporting new clinical trial data, Ionis Pharmaceuticals and AstraZeneca plan to submit an NDA for eplontersen for treating ...

Stakeholders Want Changes to Supply Chain Guidance

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Four drug industry stakeholders ask FDA to clarify elements in a draft guidance on interoperable exchange of information under the...

Pacira Seeking Expanded Label on Exparel

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Pacira BioSciences plans to submit a supplemental NDA early next year to broaden the label on its post-surgical pain drug Exparel ...

CBER Webinar 10/5 on Study Data Standards

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CBER announces a 10/5 Webinar entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission.

FDA Lifts Hold on Sarepta Duchenne Drug Trial

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FDA lifts its clinical hold on Sareptas investigational Duchenne muscular dystrophy drug SRP-5051.

Leaf of Life Marketing Illegal New Drugs: FDA

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FDA warns St. Louis, MO-based Leaf of Life that its Web site takes orders for dietary supplements that are legally considered to b...

Boston Scientifics Watchman Gets Revised Label

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FDA approves expanded labeling for Boston Scientifics Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual a...

CDER Working to Optimize Drug Absorption

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CDER scientists are working to improve the bioavailability of generic drugs that do not dissolve well in water.