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FDA Authorizes First Oral Antiviral for Treatment of COVID-19 WorldPharmaNews
December 23, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease...
First drug for acute graft-versus-host disease prevention approved by FDA EuropeanPharmaceuticalReview
December 23, 2021
BMS’s Orencia (abatacept) has been approved by the US FDA for prophylaxis of acute graft-versus-host disease (aGvHD) in patients aged two years plus.
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.
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.
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...
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.
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.
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...
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
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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