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FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea

01/01/2021
RALEIGH, N.C., December 21, 2020 — Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA)
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Medications

FDA Approves Supplemental New Drug Application for Takeda’s Iclusig (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML

12/31/2020
December 18, 2020 — Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for
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Health News

FDA approves Pfizer's coronavirus vaccine for EUA

12/12/2020
FDA panel endorses Pfizer coronavirus vaccine When will the treatment be available to the public? Infectious disease expert Dr. Amesh Adalja provides insight. The U.S. Food and Drug
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Health News

FDA to let AstraZeneca's coronavirus vaccine trials resume in the US

10/23/2020
FDA will let US trials of AstraZeneca and Oxford’s coronavirus vaccine resume – as reports emerge that it WORKS FDA regulators said on Friday that AstraZeneca can resume
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Health News

Company Seeks FDA Emergency Approval for COVID-19 Antibody Therapy

10/08/2020
WEDNESDAY, Oct. 7, 2020 — Eli Lilly and Co. is seeking U.S. approval for emergency use of an experimental antibody therapy for COVID-19. The request to the U.S.
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Health News

FDA approves Farxiga for heart failure with reduced ejection fraction

05/07/2020
The U.S. Food and Drug Administration has granted approval for Farxiga (dapagliflozin) oral tablets to treat adults with heart failure with reduced ejection fraction, the agency announced Tuesday.
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Health News

FDA has APPROVED drug Remdesivir for emergency use for coronavirus

05/01/2020
BREAKING NEWS: FDA has APPROVED experimental drug Remdesivir for emergency use for coronavirus patients, Donald Trump reveals, days after study showed it may help the worst-hit President Donald
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Health News

Johns Hopkins gets FDA OK to test blood therapies for COVID-19 patients

04/06/2020
The U.S. Food and Drug Administration approved a clinical trial Friday that will allow Johns Hopkins University researchers to test a therapy for COVID-19 that uses plasma from
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Health News

E-cigarette popularity on Instagram is still growing despite an FDA anti-vaping campaign

01/22/2020
Promotional vaping Instagram posts outnumber anti-vaping content 10,000 to 1, according to a new study published in Frontiers in Communication. Despite “The Real Cost” awareness campaign launched by
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Health News

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

09/27/2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision support
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