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FDA Gives OK to Merck's Antiviral At-Home COVID Pill
drugs
December 23, 2021
Many Americans now have two oral antiviral pills that can be taken at home to treat a fresh case of COVID-19.
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FDA Gives OK to Merck Antiviral At-Home COVID-19 Pill
drugs
December 23, 2021
Many Americans now have two oral antiviral pills that can be taken at home to treat a fresh case of COVID-19.
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FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations
FDA
December 22, 2021
FDA has approved Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism (VTE), or blood clots that form in the veins, and reduce the risk of VTE recurring in pediatric patients...
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FDA Approves Pfizer Pill as First At-Home COVID-19 Treatment
drugs
December 22, 2021
The U.S. Food and Drug Administration on Wednesday approved the emergency use of the new Pfizer antiviral pill Paxlovid in people who are at high risk for severe COVID-19.
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FDA approves AstraZeneca-Amgen’s Tezspire for severe asthma treatment
Pharmaceutical-Technology
December 21, 2021
The US Food and Drug Administration (FDA) has granted approval to AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) as an add-on maintenance therapy for severe asthma in adults and paediatric individuals of the age 12 years and above.
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CDER Conversation: CDER Creates New Biosimilars Resources for Educators, Teaching Facilities
FDA
December 20, 2021
FDA’s Center for Drug Evaluation and Research’s Office of Therapeutic Biologics and Biosimilars (OTBB) released its first-ever curriculum toolkit for educators to help students in health care professional degree programs...
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FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
FDA
December 20, 2021
FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in pediatric patients aged four up to 11 years. FDA had previously granted accelerated approval for Oxbryta for patients aged 12 years and older with sickle
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Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO™ (budesonide) to Reduce Proteinuria in IgA Nephropathy
prnasia
December 17, 2021
Everest Medicines Limited (HKEX 1952.HK) today reported that Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the US Food and Drug Administration (FDA)...
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FDA Approves Tarpeyo
Drugs
December 17, 2021
Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has approved Tarpeyo (budesonide) delayed release capsules to reduce proteinuria...
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FDA Approves First Drug to Prevent Graft Versus Host Disease
FDA
December 16, 2021
Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD), a condition that occurs when donor bone marrow or stem cells attack the graft recipient...