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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...
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...
FDA Issues Emergency Use Authorization for AstraZeneca’s EVUSHELD™ (tixagevimab co-packaged with cilgavimab), the First Antibody Therapy Authorized in the U.S. for Pre-Exposure Prophylaxis of COVID-19 prnewswire
December 13, 2021
Brand Institute is proud to announce its successful partnership with AstraZeneca in developing the brand name EVUSHELD™ and assisting with the development of the nonproprietary names tixagevimab...
50 Years of Progress in Treating Patients with Cancer FDA
December 13, 2021
By Richard Pazdur, MD, Director, Oncology Center of Excellence (OCE) and Acting Director, Office of Oncologic Diseases (OOD)
FDA expands EUA to Covid-19 booster shot of Pfizer-BioNTech Pharmaceutical-Technology
December 13, 2021
The US Food and Drug Administration (FDA) has granted expanded emergency use authorization (EUA) to Pfizer and BioNTech’s Covid-19 booster vaccine for people aged 16 years and above.
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds WorldPharmaNews
December 10, 2021
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six...

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