review," Rosebraugh says, "because at the time the application was filed, a preliminary review of the efficacy studies indicated that smokers treated with Chantix may have a superior rate of smoking cessation compared to Zyban (bupropion), another currently approved product for smoking cessation."...
The US Food and Drug Administration (FDA) has raised concerns about a postmarketing study that examined adverse neuropsychiatric events in patients who used smoking cessation drugs varenicline (Chantix, Pfizer) and bupropion (multiple brands). The FDA questions how researchers determined primary ...
Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of... Feb 14, 2025, 08:00 ETKexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA ...
Now, the Food and Drug Administration(FDA) has approved two drugs that may slow the cognitive decline destroying the lives of millions of Alzheimer’s patients. But both approvals are highly controversial. They were only based on the drugs’ ability to remove plaques (斑块), which were thought...
The drug, aducanumab, is also the first new Alzheimer's treatment approved since 2003. However, in 2019, aducanumab was nearly abandoned after it appeared unlikely to succeed in two clinical trials. But after reanalyzing more data, the drug's developer Biogen saw signs indicating the drug might...
IZERVAY dosing approved beyond 12 months TOKYO, Feb. 12, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) approved expande...
Ozempic, Rybelsus or Mounjaro might be prescribed "off-label" by some doctors for weight loss in people who do not have type 2 diabetes, but your insurance may not cover it for this use. Off-label means your doctor may prescribe a drug for a use not specifically approved by the FDA ...
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 34 th EDITION THEPRODUCTSINTHISLISTHAVEBEENAPPROVEDUNDER SECTION505OFTHEFEDERALFOOD,DRUG,ANDCOSMETICACT. U.S.DEPARTMENTOFHEALTHANDHUMANSERVICES FOODANDDRUGADMINISTRATION CENTERFORDRUGEVALUATIONANDRESEARCH ...
The US Food and Drug Administration (FDA) has granted marketing approval for the BrainsWay deep transcranial magnetic stimulation (TMS) system to help adult smokers kick tobacco. This is the company's third FDA-approved indication for its deep TMS system and the first FDA approval for any TMS ...
List of Approved Drug Products containing Metoprolol Tartrate in the FDA Orange Book on PharmaCompass.com