new drug application
Johnson & Johnson submits FDA application for Caplyta to prevent schizophrenia relapse
July 18, 2025Medical Communications, Research and Development CAPLYTA, Johnson & Johnson, Neurology, US Food and Drug Administration, neuroscience, new drug application, schizophrenia
Johnson & Johnson has submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Caplyta …
Pharvaris to report phase 3 data and submit New Drug Application
July 15, 2025Medical Communications, Research and Development Pharvaris, Rare Diseases, US Food and Drug Administration, clinical trial, genetic condition, new drug application
Pharvaris has announced that its data from its phase 3 study of deucrictibant immediate-release capsules (IR) for the treatment of …
Verona Pharma submits FDA New Drug Application for COPD treatment
June 27, 2023Research and Development COPD, Cardiology, FDA, ensifentrine, new drug application, verona pharma
UK-based Verona Pharma has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug …
GSK announces extension of FDA’s review for momelotinib
June 20, 2023Medical Communications FDA, GSK, Oncology, momelotinib, new drug application
GSK has announced that the US Food and Drug Administration (FDA) has extended its review period for the new drug …
Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review
July 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing Johnson & Johnson, US FDA, WHO, drug trial, new drug application, regulation, soil-transmitted helminthiasis
Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New …
Lilly awaits FDA review of new arthritis treatment
January 20, 2016Manufacturing and Production, Research and Development, Sales and Marketing Eli Lilly, FDA, Incyte, NDA, baricitinib, lilly, new drug application, rheumatoid arthritis
Eli Lilly has submitted a new drug application (NDA) to the FDA for baricitinib as a treatment for moderate-to-severe rheumatoid …
Novo Nordisk files for new insulin approval
December 10, 2015Manufacturing and Production, Research and Development, Sales and Marketing FDA, NDA, Novo Nordisk, NovoLog, diabetes, insulin aspart, new drug application
Novo Nordisk has submitted a New Drug Application (NDA) for faster-acting insulin aspart to the FDA. If successful, the Danish …
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FibroFind appoints Lee Borthwick as CEO
