FDA Approval Articles



Esperion Announces FDA Confirmation of Regulatory Pathway to Approval for the Combination of Bempedoic Acid and ...
GlobeNewswire (press release)
ANN ARBOR, Mich., June 26, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for ...

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06/26/2017 09:05 PM


FiercePharma

After a painfully slow 2016, FDA's racking up drug approvals lickety-split
FiercePharma
Halfway into 2017, the FDA has beaten last year's drug-approvals tally with a crop featuring controversy, sales firepower and one very high price. Friday's approval for the Portola anticoagulant Bevyxxa pushed the count for this year to 23, surpassing ...

06/26/2017 04:26 PM


ConforMIS (CFMS) Gets FDA Approval for iTotal Hip System
Nasdaq
Medical technology company, ConforMIS, Inc.CFMS recently announced the receipt of FDA 510(k) clearance for its primary iTotal Hip replacement system. The ConforMIS iTotal Hip system features proprietary iFit image-to-implant technology. The system ...

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06/26/2017 03:55 PM


FDA approval, atopic dermatitis study top dermatology reads for week
Healio
The FDA announced today that it has approved Baxdela to treat acute bacterial skin and skin structure infections. Baxdela (delafloxacin, Melinta Therapeutics) is an antibacterial drug available for intravenous and oral use, according to a news release ...

06/26/2017 02:05 PM


Roche's (RHHBY) Combination Cancer Remedy Wins FDA Approval
Zacks.com
Roche (RHHBY) announced that the FDA has granted approval to the subcutaneous injection of its marketed lymphoma drug MabThera/Rituxan as Rituxan ...

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06/26/2017 01:53 PM


Motley Fool

The FDA Has Never Approved a Drug Like This in Its 111-Year ...
Motley Fool
This cancer drug produced data so incredible that the FDA approved it immediately for a specific genetic mutation, regardless of cancer location.

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06/25/2017 12:41 PM