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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.
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Lupin gets tentative US FDA nod for generic tablets to treat high BP
ExpressPharma
December 28, 2021
Lupin recently said it has received tentative approval from the US health regulator for its generic Azilsartan Medoxomil tablets used to treat high blood pressure.
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FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults
WorldPharmaNews
December 28, 2021
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing...
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FDA Approves Apretude
Drugs
December 27, 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders...
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Evusheld to prevent Covid-19: There won't be nearly enough for Americans who are eligible
FirstWordPharma
December 27, 2021
The US government has only contracted for enough doses of AstraZeneca's Evusheld to cover less than one-tenth the number of people who are eligible for it, reported CNN.