FDA

Pfizer Group B strep vaccine for infants returns encouraging mid-stage trial results
Streptococcus agalactiae bacteria, responsible for vaginal and urinary tract infections and newborn infections including meningitis and septicemia. Optical microscopy view. Cavallini James | BSIP | Universal Images Group | Getty Images Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising […]
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Biden administration asks Pfizer, Moderna and Novavax for ‘reasonable’ prices on updated Covid vaccines
A nurse prepares doses of the Pfizer vaccine on Dec. 30, 2021, during a COVID-19 vaccination event at Josephine’s Southern Cooking in Chatham, Illinois. Brian Cassella | Tribune News Service | Getty Images The Biden administration on Thursday urged Pfizer, Moderna and Novavax to price their updated Covid vaccines at a “reasonable” rate when they […]
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FDA approves first over-the-counter birth control pill
HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. Source: Perrigo The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent […]
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Sales of Alzheimer’s drug Leqembi may be slow initially but could pick up in 2024
Jay Reinstein, who suffers from Alzheimer’s, receives an injection so he can have a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023. Michael Robinson Chávez | The Washington Post | Getty Images Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick […]
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As drugmakers race to develop the next big weight loss pill, Eli Lilly may have an edge
An Eli Lilly & Co. logo is seen on a box of insulin medication in this arranged photograph at a pharmacy in Princeton, Illinois. Daniel Acker | Bloomberg | Getty Images Drugmakers are jockeying to capitalize on the next major innovation coming to the blockbuster weight loss industry: effective, convenient and potentially affordable obesity pills. […]
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Novo Nordisk says high-dose experimental obesity pill leads to 15% weight loss
Novo Nordisk said that it was cutting the supply of some doses of its popular obesity drug in the U.S. as it struggles to keep up with surging demand. Liselotte Sabroe | Afp | Getty Images Novo Nordisk‘s high-dose experimental obesity pill helped overweight or obese adults lose around 15% of their body weight, according […]
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Pfizer, Moderna and Novavax gear up for fall Covid vaccine rollout with an important head start
A pharmacist prepares to administer COVID-19 vaccine booster shots during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center on September 09, 2022 in Chicago, Illinois. Scott Olson | Getty Images The U.S. Food and Drug Administration’s Covid strain selection for the next round of shots puts Pfizer, Moderna […]
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FDA advisors raise doubts about seasonal updates to Covid vaccines as with flu shots
A person receives a COVID-19 vaccination dose, during a free distribution of COVID-19 rapid test kits for those who received vaccination shots or booster shots, at Union Station on January 7, 2022 in Los Angeles, California. Mario Tama | Getty Images The U.S. Food and Drug Administration’s independent panel of advisors raised doubts about the […]
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FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
A woman receives a booster dose of the Moderna coronavirus disease (COVID-19) vaccine at a vaccination centre in Antwerp, Belgium, February 1, 2022. Johanna Geron | Reuters The U.S. Food and Drug Administration’s independent panel of advisors on Thursday recommended that updated Covid shots for the fall and winter target one of the XBB variants, […]
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Covid vaccine maker Novavax sees a pathway to survival – but it won’t be easy
Medical syringes and Novavax logo displayed in the background are seen in this illustration photo taken in Krakow, Poland on December 2, 2021. Jakub Porzycki | NurPhoto | Getty Images Novavax has a clear message for Wall Street: The cash-strapped Covid vaccine maker sees a pathway to survival. Maryland-based Novavax said as much last month […]
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