FDA

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THE FIRST AND ONLY HYALURONIC ACID INTRADERMAL MICRODROPLET INJECTION, APPROVED FOR IMPROVED SKIN SMOOTHNESS OF THE CHEEKS IRVINE, Calif., May 15, 2023 /PRNewswire/ — Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of SKINVIVEâ„¢ by JUVÉDERM® to improve skin smoothness of the cheeks in adults over the age of 21.1 SKINVIVEâ„¢ by […]

BALTIMORE — U.S. Customs and Border Protection, and U.S. Food and Drug Administration officers sized over 25,000 bottles of a harmful weight-loss supplement, customs said Tuesday. Officials said that the FDA has not approved the supplement for sale or import into the U.S.  Packaged as African Black Soap, the boxes actually contained Apetamin, a potentially harmful […]

(Adds details, background) BENGALURU, May 2 (Reuters) – The U.S. Food and Drug Administration (FDA) has asked India’s Sun Pharmaceutical Industries Ltd to halt tests on one dose of an experimental dermatological drug due to the potential of blood clots, the company said on Tuesday. The FDA has also said that patients with alopecia areata […]

In an interview with CNBC, Dr. Robert Califf said better regulation is needed to combat health misinformation that’s rampant online. He also said the agency, though it has no direct role in drug pricing, will use its bully pulpit more. New obesity drugs bring “great hope,” Califf said, but need more data. Life expectancy in […]

March 20 (Reuters) – Staff reviewers of U.S. drug regulator on Monday did not raise any new safety concerns about Biogen Inc’s (BIIB.O) experimental drug for treating a rare type of amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.

March 10 (Reuters) – The U.S. Food and Drug Administration approved Acadia Pharmaceuticals Inc’s (ACAD.O) drug for the treatment of Rett syndrome, a genetic brain disorder, the company said on Friday, making it the first approved drug for the condition.

March 7 (Reuters) – The U.S. Food and Drug Administration (FDA) has extended the review of BioMarin Pharmaceutical Inc’s (BMRN.O) experimental gene therapy for adults with a severe bleeding disorder, the latest delay in the company’s quest to gain approval in the country.

Jan 23 (Reuters) – The U.S. health regulator on Monday proposed the use of one dose of the latest updated COVID-19 shot annually for most people, similar to the influenza immunization campaign, as it moves to simplify the country’s vaccination strategy. Currently, people in the United States need to first get two doses of the […]

Jan 13 (Reuters) – (This Jan. 13 story has been refiled with an edited headline to clarify that the link to a stroke is possible, not definite.) A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE . . .

Jan 7 (Reuters) – The U.S. Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in . . .


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