FDA Approval Articles



Labmate Online

Reference Standards Acquires FDA Approval for Oncology Companion Diagnostic Test
Labmate Online
Horizon Discovery Group plc has announced the use of its Reference Standards in a recent successful premarket approval application (PMA) filing with the FDA for a companion diagnostic in oncology by a leading next generation sequencing company.

08/17/2017 02:30 PM


RedHill Biopharma (RDHL) Granted FDA Approval US Commercialization Agreement for GI Product Esomeprazole ...
StreetInsider.com
Esomeprazole Strontium DR Capsules 49.3 mg is a proprietary prescription drug approved by the FDA under a New Drug Application (NDA). Craig Miller, RedHill's VP U.S. Business Operations, Market Access, said: “RedHill's U.S. commercial operations, ...

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08/17/2017 12:09 PM


TheStreet.com

New Studies Cast Doubt on FDA Approval Process
TheStreet.com
Huseyin Naci of the London School of Economics and one of the authors of the drug study wrote, "Although (the acceleration) can be highly effective in facilitating the approval of certain new drugs . . . approved via expedited pathways may have greater ...

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08/17/2017 11:03 AM


OncLive

FDA Approval Sought for Frontline Cabozantinib in RCC - OncLive
OncLive
A supplemental New Drug Application (sNDA) has been submitted to the FDA for cabozantinib as treatment for previously untreated patients with advanced ...
Exelixis (EXEL) Sends In Supplemental NDA For CabometyxEconomic Calendar

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08/16/2017 07:49 PM


Drug Store News

Perrigo gets FDA approval for generic Mycolog II cream - Drug Store ...
Drug Store News
SILVER SPRING, Md. — Perrigo has received Food and Drug Administration approval for its generic of Mycolog II cream (nystatin and triamcinolone acetonide ...
Perrigo announces generic cream final FDA approval - News ...HollandSentinel.com

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08/16/2017 07:18 PM


FDA OK of Aerie Pharma glaucoma drug jeopardized by factory ...
STAT
A glaucoma drug developed by Aerie Pharmaceuticals is under review by FDA, but the decision hinges on a dysfunctional manufacturing facility.

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08/16/2017 05:56 PM