You are here: Industry Insights > FDA

News List

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...
New US FDA Clinical Evaluation Proves Non-Contact Thermometers Fail To Meet Accuracy Specifications prnewswire
December 10, 2021
Since the start of the pandemic, non-contact infrared thermometers (NCITs) have been widely used as a screening method for fever detection in healthcare and public settings, as fever is a leading sign of Covid.
FDA Authorises Emergency Use of Pfizer Boosters for Those Aged 16-17 Drugs
December 10, 2021
The U.S. Food and Drug Administration on Thursday approved the emergency use of Pfizer's coronavirus booster shots for Americans aged 16 and 17.
FDA OKs Antibody Cocktail to Help Immune-Compromised Fend Off COVID Drugs
December 10, 2021
The U.S. Food and Drug Administration on Wednesday granted emergency approval of a new antibody cocktail to prevent COVID infection in people who have weakened immune systems or who can't tolerate COVID vaccines.
FDA Priority Review for supplemental Biologics License Application for Reblozyl® in Adults with Beta Thalassemia AmericanPharmaceuticalReview
December 06, 2021
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl® (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults...
FDA Priority Review for BLA for Merck’s VAXNEUVANCE for Use in Infants and Children AmericanPharmaceuticalReview
December 02, 2021
Merck announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal...
FDA Advisory Committee Votes for Oral Antiviral Molnupiravir to Treat COVID-19 in High Risk Adults AmericanPharmaceuticalReview
December 02, 2021
Merck and Ridgeback Biotherapeutics provided the following statement at the conclusion of the FDA Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801)...

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page