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Juvderm Volux XC Approved for Jawline Shaping

[ Price : $8.95]

FDA approves Allergan Aesthetics Juvderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to s...

E-submission Guide for Expedited Safety Reports

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-...

FDA Approves Cimerli as Generic Lucentis

[ Price : $8.95]

FDA approves Coherus Cimerli as an interchangeable generic version of Genentechs Lucentis for all five label indications.

Looking at the FDA/Industry Revolving Door

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A Grid news report uses Linkedin data to estimate how many former FDAers are now working in regulated companies and discusses the ...

Alnylam Pharmaceuticals Plans NDA for Patisiran

[ Price : $8.95]

Alnylam Pharmaceuticals plans to file an NDA submission late this year for patisiran, indicated for treating transthyretin-mediate...

Panel To Review Amylyx ALS Drug

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Federal Register notice: FDA announces a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting that will revi...

Glaukos 510(k) Cleared for Intraocular Pressure

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FDA clears a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce...

False Claims Liability for Medical Device Off-Label Use

[ Price : $8.95]

Attorney Keeley McCarty says a recent government suit against Promothesus Group demonstrates the government is willing to use the ...

CGMP and Other Violations at DSP Skin Care

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FDA warns Los Angeles, CA-based DSP Skin Care about CGMP and other violations, some repeated from 2018, in its manufacturing of fi...

Allarity Refocuses in Response to FDA Comments

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Allarity Therapeutics says it is no longer economically feasible to pursue its dovitinib as a monotherapy for some renal cancers a...