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Acadia Pharma sNDA for Nuplazid

[ Price : $8.95]

Acadia Pharmaceuticals files a supplemental NDA to support a potential new indication for Nuplazid (pimavanserin) treating halluc...

Allergan Approved for Augmenting the Chin

[ Price : $8.95]

FDA approves Allergan Aesthetics Juvderm Voluma XC for augmenting the chin region in adults.

FDA Nixes Hydroxychloroquine Emergency Use

[ Price : $8.95]

FDA revokes the emergency use authorization that allowed chloroquine phosphate and hydroxychloroquine sulfate to be used to treat ...

Canon Medical MRI Speeder Cleared

[ Price : $8.95]

FDA clears a Canon Medical 510(k) for the compressed Speeder technology for the companys Vantage Orian 1.5T MRI system that is int...

Mercks Gardasil 9 Expanded Indication

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FDA approves Mercks Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant) for preventing oropharyngeal and other h...

Q&A Page For Device Adverse Event Reports

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FDA posts a question and answer Web page to address adverse event reporting for medical devices distributed under Emergency Use Au...

Safety Alert on Remdesivir Interactions

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A new FDA safety alert warns health care providers about a newly discovered potential drug interaction related to Gilead Sciences ...

3rd Complaint Filed in Generic Drug Price-Fixing Case

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Some 51 states and territories file a third complaint in Connecticut federal court alleging that 26 generic drug companies conspir...

FDA Grant to Fund Pediatric Device Challenge

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An FDA grant and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, will fund a product development com...

Viela Bio BLA for Optic Rare Disease Approved

[ Price : $8.95]

FDA approves a Viela Bio BLA for Uplizna (inebilizumab-cdon) injection for intravenous use for treating neuromyelitis optica spect...