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Do Not Use At-Home COVID Test Swabs in the Throat: FDA drugs
January 10, 2022
Swabs that come with at-home rapid antigen COVID-19 tests should be used in the nose and not the throat, the U.S. Food and Drug Administration warns.
How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product FDA
January 07, 2022
CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products.
Alembic Pharmaceuticals receives US FDA tentative approval for Vortioxetine tablets ExpressPharma
January 07, 2022
The tablets are indicated for the treatment of Major Depressive Disorder (MDD)
FDA Shortens Time to Booster After Moderna Vaccine to Five Months drugs
January 07, 2022
Citing the rapid spread of the omicron variant and the need for protection against it, U.S. federal health officials are shortening the recommended time between the second dose of the Moderna vaccine and a booster shot from six months down to five.
FDA expands EUA of Pfizer-BioNTech’s Covid-19 booster shot to adolescents Pharmaceutical-Technology
January 05, 2022
The US Food and Drug Administration (FDA) has granted an expanded emergency use authorization (EUA) for the Pfizer and BioNTech’s Covid-19 vaccine’s booster dose to adolescents aged 12 years and above.
FDA Approves Adbry drugs
January 05, 2022
FDA Approves Adbry (tralokinumab-ldrm) for Adults with Moderate-to-Severe Atopic Dermatitis
Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine prnewswire
January 04, 2022
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to...
NRx seeks breakthrough therapy designation for Covid-19 treatment Pharmaceutical-Technology
January 04, 2022
In a randomised trial, the therapy demonstrated a statistically significant two-fold increased odds of survival.
FDA Authorizes Emergency Use Pfizer Booster Shots for Kids Aged 12-15 drugs
January 03, 2022
The U.S. Food and Drug Administration on Monday approved the emergency use of Pfizer's booster shot against COVID-19 for youths aged 12 to 15.
Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation Drugs
December 29, 2021
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...

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