… cytisinicline was submitted to the FDA for approval on June 26 … nicotine that are authorized for marketing by the Food and Drug … Life Sciences submitted to the FDA a new drug application last … and bronchitis. Last October, the FDA and the National Institutes of …

… has brought several pivotal FDA approvals that are expanding … of the most impactful FDA authorizations shaping clinical … practice in 2025. The FDA approved gepotidacin (Blujepa; GSK … effective treatment. The FDA granted marketing authorization for the Visby …

… , Vevzuo and Evfraxy, have received marketing authorisation in the European Union … US Food and Drug Administration (FDA) approved 19 biosimilars – a significant …

… AB22007) has been authorized by FDA and EMA (harmonized protocol … 3 study by both the FDA and EMA represents a … study has been validated by FDA and EMA. The establishment … be successful or to the marketing authorizations granted by competent authorities …

… dosing. Last year, the FDA approved biweekly dosing, giving … therapy, was a conditional marketing authorization that requires Regeneron to … patient benefit. Similarly, the FDA decision is an accelerated … antibody is currently under FDA review as a potential …

… Food and Drug Administration (FDA) has granted Lynozyfic (linvoseltamab … and seven years of marketing exclusivity upon approval. Fast … frequent communication with the FDA and allows the … debilitating diseases. Reference “FDA grants accelerated approval to …

… (1). Firsts for FDA multiple myeloma approvals In … myeloma treatment. “The FDA approval of Lynozyfic reinforces … in Europe. A conditional marketing authorization granted by the … Lynozyfic (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of …

… increase (2.3%). Zanidatamab received FDA approval as a treatment for … Jazz Pharmaceuticals receives European Commission marketing authorization for Ziihera® (zanidatamab) for … Jazz Pharmaceuticals announces U.S. FDA approval of Ziihera® (zanidatamab-hrii …

… to Hydroxie, LLC, for illegally marketing products containing 7-hydroxymitragynine (7 … The FDA’s letter highlights multiple violations, including: The illegal marketing of … osteoarthritis, and depression, without any FDA evaluation for safety or effectiveness …

… .S. Food and Drug Administration (FDA) has accepted and granted priority … of clinical worsening events. The FDA has set a Prescription Drug … , of October 25. The supplemental marketing application is based on Phase …