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Alembic Pharmaceuticals receives US FDA tentative approval for Dronedarone tablets
ExpressPharma
January 11, 2022
Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation
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FDA reduces time for Moderna Covid-19 vaccine booster to five months
Pharmaceutical-Technology
January 11, 2022
Common booster shot side effects include injection area pain, redness and swelling and fatigue.
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FDA Warns Against Using At-Home COVID-19 Test Swabs in the Throat
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.
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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.
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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.
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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...