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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.
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)...
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...
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...
FDA Approves Entadfi Drugs
December 14, 2021
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer...
Heron Therapeutics Announces FDA Approval of an Indication Expansion for Zynrelef for Postoperative Pain Management Drugs
December 14, 2021
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs...
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older AmericanPharmaceuticalReview
December 13, 2021
Pfizer Inc. and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 16 years of age and older. The booster dose is to be administered at...
Lupin recalls 4,113 cartons of oral contraceptive medicine in US market expresspharma
December 13, 2021
The affected lot has been produced at the company’s Pithampur-based manufacturing facility in Madhya Pradesh and distributed in the US by Baltimore-based Lupin Pharmaceuticals...

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