FDA Approves Vaxneuvance

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults KENILWORTH, N.J.–(BUSINESS WIRE)– (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae […]

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FDA adds warning of rare reaction risk to Johnson & Johnson COVID vaccine

WASHINGTON — U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem. The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness […]

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FDA Approves Rylaze

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic […]

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FDA extends Johnson & Johnson COVID-19 vaccine expiration dates

Pfizer now testing COVID-19 vaccine on children ages 5-11 Fox News medical contributor Dr. Janette Nesheiwat discusses Pfizer’s tests and the Moderna CEO announcing that the vaccine will be available to kids by this fall WASHINGTON – Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by an extra […]

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FDA approves first drug to treat Alzheimer's patients since 2003

FDA approves first drug to treat Alzheimer’s patients since 2003 despite controversy over mixed clinical trial results On Monday, the FDA approved aducanumab, which was developed by Biogen Inc, to treat Alzheimer’s disease The drug removes amyloid beta proteins from the brain and could slow down patients’ cognitive decline  Aducanumab is not only the first drug of its kind  but also […]

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FDA OKs monoclonal antibody COVID-19 therapy for mild-to-moderate illness

Fox News Flash top headlines for May 27 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The Food and Drug Administration (FDA) on Wednesday granted emergency use authorization to a monoclonal antibody therapy to treat mild-to-moderate COVID-19 in adults and pediatric patients ages 12 and older who are considered at high risk for progression to […]

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FDA expected to OK Pfizer’s COVID-19 vaccine for teens within week – The Denver Post

WASHINGTON — The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year. The announcement is set to come a month after the company […]

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FDA Revokes Emergency Use of Solo Bamlanivimab for COVID

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has granted Eli Lilly’s request to revoke emergency use authorization for the COVID-19 monoclonal antibody therapy bamlanivimab when used as a monotherapy, saying the evidence indicates that it is likely not effective against currently circulating variants. The agency said in […]

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FAQ: What to Know About the J&J Vaccine Pause

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. After receiving reports of a rare blood clot in people receiving the Johnson & Johnson COVID-19 vaccine, the FDA and the CDC have recommended a pause in the use of the vaccine, pending further investigation. Here is what you need to know: Why was the pause […]

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