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A Short Seller s Case Against a Medical Devices Company Just Got Even Weirder

New clues have emerged in the mystery surrounding the creation of Dr. Antik Bose the fake doctor with an elaborate social media profile full of fancy cars and ostentatious homes who purported to be the author of scientific research connected to Penumbra, the controversial medical device company.   Short seller Gabriel Grego of Quintessential Capital Management launched a short attack on Penumbra more than a month ago, claiming the catheters it produces for stroke patients were not safe.    Late Tuesday afternoon, the Food and Drug Administration said that it had requested Penumbra voluntarily remove the catheter, called the JET 7 Xtra Flex, from the market to protect patients. The FDA said it has received over 200 medical device reports, including 14 unique patient deaths, related to the catheter. Penumbra has begun the recall.

FDA review clears path for Moderna coronavirus vaccine

By CAROLYN Y. JOHNSON | The Washington Post | Published: December 15, 2020 Stars and Stripes is making stories on the coronavirus pandemic available free of charge. See other free reports here. Sign up for our daily coronavirus newsletter here. Please support our journalism with a subscription. By the end of the week, the United States could have two coronavirus vaccines. A vaccine candidate developed by biotechnology company Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was 94% effective in a clinical trial and carried no serious safety concerns. The 54-page document positions the Moderna vaccine to follow the same historic track as the Pfizer-BioNTech vaccine. After the FDA gave a positive review of the Pfizer-BioNTech vaccine exactly a week ago, the shots were endorsed by a panel of outside experts on Thursday and granted a green light by regulators a day later. The fi

FDA review clears path for second coronavirus vaccine, this one developed by Moderna

FDA review clears path for second coronavirus vaccine, this one developed by Moderna Carolyn Y. Johnson, The Washington Post Dec. 15, 2020 FacebookTwitterEmail By the end of the week, the United States could have two coronavirus vaccines. A vaccine developed by biotechnology company Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was highly effective in a clinical trial and carried no serious safety concerns. The FDA is likely to authorize the Moderna vaccine as soon as Friday, according to a person with knowledge of the situation who spoke on the condition of anonymity because they were not authorized to discuss the issue. Anticipating that decision shortly, Gen. Gustave Perna, who is overseeing the federal effort to distribute vaccines, said Monday that the United States was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first w

US Food and Drug Administration review clears path for second coronavirus vaccine, this one developed by Moderna

It will be a very similar cadence that was executed this week with Pfizer, where we re hitting initial sites on Monday, follow on Tuesday and Wednesday, Perna said. The 54-page FDA document published Tuesday morning positions the Moderna vaccine to follow the same historic track as the Pfizer-BioNTech vaccine. After the agency gave a positive review of the Pfizer-BioNTech vaccine exactly a week ago, the shots were endorsed by a panel of outside experts on Thursday and granted a green light by regulators a day later. The first doses were administered to health care workers on Monday. Regulators said the two-shot Moderna regimen was particularly effective against severe disease. There were 30 cases of severe Covid-19, the disease caused by the virus, in the trial, none of them in the group that got the vaccine.

Moderna vaccine s safety and effectiveness confirmed by FDA

Moderna vaccine s safety and effectiveness confirmed by FDA
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