Janssen applies to FDA New Drug Application for Invokamet XR
Janssen Research & Development, LLC has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Invokamet extended release (XR).
Pharmaceuticals, Biotechnology and Life Sciences
Janssen Research & Development, LLC has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Invokamet extended release (XR).
Bayer has submitted an application for marketing authorization in both the European Union and in the United States for LCS-16, a new low-dose levonorgestrel-releasing intrauterine system
Sanofi and AstraZeneca have announced a direct exchange of 210,000 compounds from their respective, proprietary compound libraries.
Mylan’s subsidiaries were sued Warner Chilcott and Qualicaps in connection with the filing of an ANDA with the FDA for Mesalamine Delayed-release Capsules.
The Food and Drug Administration (FDA) revealed Thursday latest products it had found containing hidden drug ingredients.
The prescriber certification deadline for new Clozapine REMS Program has been extended from November 23 to December 14. Due to…
The Food and Drug Administration (FDA) has issued a notice in which it advises consumers not to purchase or use XForMan Plus,…
Judge Peter Kirwan of the Superior Court of California for the County of Santa Clara has granted Depomed motion for…
The U.S. Food and Drug Administration approved Narcan nasal spray on Wednesday. Narcan is the first FDA-approved nasal spray version of…
Eli Lilly and Merck are moving on with an existing oncology clinical trial collaboration to evaluate the safety and efficacy of the combination of Lilly’s Almita (pemetrexed for injection) and Merck’s Keytruda (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC).