FDA Approval Articles


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09/21/2017 09:04 PM

Many drug companies fail to conduct timely safety checks on medicines after FDA approval
With President Donald Trump vowing to further speed the FDA approval process, “Drug approval is likely to become increasingly rapid and rely on looser evidence standards,” the Woloshin team writes in its report. “It will be crucial to ensure that the ...

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09/21/2017 05:20 PM


After a 'game changing' FDA approval, a former HHS official says mobile apps will reshape addiction treatment
Last week, the FDA approved Reset, the first mobile medical application to treat substance abuse disorders in conjunction with outpatient therapy. Manufactured by Pear Therapeutics, the app delivers cognitive behavioral therapy to assist with treatment ...

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09/21/2017 04:52 PM

Abiomed receives FDA PMA approval for Impella RP for right heart failure; shares ahead 2% premarket
Seeking Alpha
Abiomed (NASDAQ:ABMD) announces that it has received FDA premarket approval (PMA) for the Impella RP heart pump for providing temporary right ventricular support for up to 14 days in patients with a minimum body surface area (at least 1.5 m2) who ...

09/21/2017 02:32 PM

Schaeffers Research (blog)

BioCryst's RAPIVAB® (peramivir injection) Receives FDA Approval for a Pediatric Indication
GlobeNewswire (press release)
Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two ...
Can BioCryst Turn Itself Around With This FDA Approval?24/7 Wall St.
AMD, Alphabet Make Big Moves; FDA Approval Boosts BioCrystSchaeffers Research (blog)

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09/21/2017 11:01 AM

Abiomed Receives FDA PMA Approval for Impella RP® for Right Heart Failure
GlobeNewswire (press release)
20, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the ...

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09/20/2017 10:32 PM