getty On 19 February 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) dealt a serious blow to China’s “me-too” drug-makers hoping that China-derived data will grant them access to the US mark...
Tag: FDA
Family Dollar Products Contaminated By Rodents, Birds, Urine, Feces In 6 States
Family Dollar has issued a voluntary recall of various products sold at 404 different stores in … [+] Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. (Photo by Robert Alexande...
Baby Formula Recall After 4 Infants Hospitalized Includes Similac, Alimentum, EleCare
Abbott Nutrition’ has issued a voluntary recall of certain Similac, Alimentum, EleCare infant … [+] formula products that were produced at their Sturgis, Michigan, facility. (Photo: Getty) getty...
Senate confirms Biden FDA pick Califf, despite objections to drug industry ties
Robert Califf testifies during the Senate Health, Education, Labor and Pensions Committee hearing on the nomination to be commissioner of the Food and Drug Administration on Tuesday, Dec. 14, 2021. Bi...
Despite FDA Approval, Expectations Are Too High, Says Raymond James
At long last, following a year of Covid delays, Sensonics (SENS) received the FDA’s nod of approval for its long-lasting continuous glucose monitoring system (CGM). The Diabetes device maker’s Eversen...
FDA plan to fast-track Pfizer vaccine for kids under 5 fails
Parents of children under 5 will have to wait until at least April to get their kids vaccinated against Covid-19, after the Food and Drug Administration and Pfizer this week abruptly delayed plans to ...
FDA committee votes against Eli Lilly cancer treatment over concerns trials conducted only in China
The outside of the Food and Drug Administration headquarters is seen in White Oak, Md. Al Drago | CQ Roll Call | Getty Images A Food and Drug Administration committee on Thursday recommended against f...
Pfizer CEO says chances are ‘very high’ FDA will approve low-dose Covid shots for kids under 5
Pfizer CEO Albert Bourla on Tuesday said he believes the Food and Drug Administration will authorize the company’s Covid vaccine for children under 5 years old under a fast-track process that al...
at-home testing, from Covid to cancer, worth $2 billion dollars
The at-home testing market is bigger than just Covid tests, and it’s bigger than over-the-counter pregnancy tests. In fact, the emerging marketplace of consumer-initiated lab testing may be wort...
Moderna receives full FDA approval: is it time to buy the stock?
Moderna Inc (NASDAQ: MRNA) is now in the “oversold” territory after a 65% hit to its stock price over the past six months, says Sanctuary Wealth’s chief investment officer. Why Kilbu...
Pfizer Stock Topples After FDA Rejects OPKO-Partnered Rare Disease Drug
Pfizer stock skidded Monday after the Food and Drug Administration rejected its rare-disease drug — leading a smaller decline for similarly jilted Merck stock. X The companies received Complete Respon...
Neurometrix up 35% after receiving FDA Breakthrough Designation for its Quell tech
NeuroMetrix Inc. (NASDAQ: NURO) shot up 35% after announcing that the FDA awarded it Breakthrough Device Designation for its Quell technology. This innovative technology is designed to help reduce sev...
FDA shortens Moderna booster waiting period to 5 months for adults
A healthcare worker prepares a syringe with the Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the COVID-19 pandemic in Manhattan in New York City, Janua...
FDA Cuts Moderna Booster Waiting Period From Six Months To Five
Topline Adults who received the Moderna Covid-19 vaccine series now only need to wait five months before receiving a booster dose, the Food and Drug Administration said on Friday, days after the agenc...
Why Biogen’s Alzheimer’s drug Aduhelm is so controversial
The U.S. Food and Drug Administration’s approval of Biogen’s Alzheimer’s drug Aduhelm in June was heralded as a historic triumph in the fight against a disease that kills thousands o...
Genprex up by 130% after receiving FDA fast track designation
Genprex Inc (NASDAQ: GNPX) is a clinical-stage gene therapy organization that concentrates on the development of life-changing gene therapies to treat people with diabetes and cancer. The company anno...
Immix Biopharma’s stock rockets after pediatric cancer treatment granted RPD by the FDA
Shares of Immix Biopharma Inc. IMMX, +9.20% rocketed 66.0% in premarket trading Monday, after the biopharmaceutical company said its IMX-110 was granted Rare Pediatric Disease (RPD) designation by the...