FDA Considers Narrowing Label of PD-1 Drugs in Stomach Cancer Ahead of Adcomm Meeting If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1...
MicroPort receives CFDA approval for its EasyFinder steerable curve mapping catheter, enabling precise and effective diagnostic procedures in cardiac care.
Presents articles pertaining to the approvals made by the United States Food and Drug Administration (FDA) on ophthalmic drugs. Application approved by the FDA from KeraVision Inc. to finish enrolling patients in the Intacs clinical trials for myopia treatment; Completion of the clinical trials of...
Breaking NewsLizzy Lawrence STAT Plus:Michelle Tarver to lead FDA medical device center Morning RoundsTheresa Gaffney Morning Rounds: RFK fears, an ‘epic’ FDA fight, Marburg update HealthKathryn Kranhold STAT Plus:Former FDA lawyers join tobacco industry in ‘epic’ fight against the agency ...
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for information on a citizen petition asking the FDA to amend the standard of identity for pasteurized...
News of the potential approval comes as the FDA is demanding more research into many sunscreen ingredients currently on the U.S. market, over safety questions. The FDA has also been facing criticism from members of Congress, frustrated with the gulf between the U.S. market versus the newer...
"Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system," the FDA's Dr. John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, said in a ...
"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children,"(1,2) said Anna...
In conjunction with today’s approval, the FDA is providing all prescribers with important information for prescribing Paxlovid properly and safely, such as dosing instructions, potential side effects and information regarding drugs that may cause drug-drug interacti...
Nov 13, 2024, 18:02 ETPTC Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the... ...