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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)
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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.
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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.
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FDA Approves Adbry
drugs
January 05, 2022
FDA Approves Adbry (tralokinumab-ldrm) for Adults with Moderate-to-Severe Atopic Dermatitis
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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...
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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.
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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.
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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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Radius Announces Update on Tymlos (abaloparatide) Label
Drugs
December 29, 2021
Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) today announced that the U.S. Food and Drug Administration (FDA) has approved updates to the Tymlos label, including the removal of the boxed warning regarding the risk of osteosarcoma.
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FDA Says Rapid At-Home COVID-19 Tests Not as Sensitive to Omicron
drugs
December 29, 2021
Early research suggests that some rapid COVID-19 tests may be less able to detect the omicron variant, the U.S. Food and Drug Administration said Tuesday.