Clinical study reports (CSRs) are comprehensive, standardized reports on clinical trials that pharmaceutical companies submit to authorities such as the European Medicines Agency (EMA) during drug approval procedures. In ...
Dec 2, 2021
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Imagine being able to go to your local pharmacy and pick up a bottle of pills to treat COVID-19 that would have you feeling better in days. Soon, that could be the reality because the U.S. Food and Drug Administration is ...
Nov 29, 2021
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Just in the nick of time for the holidays, as families prepare to gather again in record numbers, a Centers for Disease Control and Prevention (CDC) panel today unanimously endorsed Pfizer and Moderna's COVID-19 booster shots ...
Nov 22, 2021
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The Food and Drug Administration provides less stringent oversight of overseas research trials used in deciding whether to approve a drug than those conducted domestically. That was the finding of my recent study, published ...
Nov 15, 2021
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If the U.S. Food and Drug Administration wants to know whether it should follow through on its proposed menthol cigarette ban, it need only look to Canada for an answer.
Nov 10, 2021
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U.S. regulators are delaying their decision on Moderna's COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation, the company said Sunday.
Nov 1, 2021
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A new Alzheimer's drug from Biogen brought in only $300,000 in sales during its first full quarter on the market, extending a slow debut complicated by coverage questions and doctor concerns.
Oct 20, 2021
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COVID-19 vaccine choices are getting more complicated. So don't feel bad if you are confused about the different COVID-19 vaccines and who's eligible for what. In addition to the three original vaccines approved by the Food ...
Oct 8, 2021
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(HealthDay)—Pfizer is expanding the recall of its anti-smoking drug Chantix (varenicline), the company announced Friday.
Sep 17, 2021
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During the next few weeks or months, you might find yourself dropping by the doctor's office or pharmacy to get your annual flu shot along with a dose of COVID vaccine.
Sep 15, 2021
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