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new drug application

Showing 7 posts of 7 posts found.

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Johnson & Johnson submits FDA application for Caplyta to prevent schizophrenia relapse

July 18, 2025
Medical 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 …

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clinical_trial-web

Pharvaris to report phase 3 data and submit New Drug Application

July 15, 2025
Medical 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 …

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lungs

Verona Pharma submits FDA New Drug Application for COPD treatment

June 27, 2023
Research 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 …

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GSK announces extension of FDA’s review for momelotinib

June 20, 2023
Medical 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 …

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johnson_and_johnson_jj

Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review

July 14, 2016
Manufacturing 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 …

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eli_lilly_logo

Lilly awaits FDA review of new arthritis treatment

January 20, 2016
Manufacturing 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 …

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Novolog pen

Novo Nordisk files for new insulin approval

December 10, 2015
Manufacturing 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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