Drug Approval | June 17, 2024
Alembic announces USFDA final approval for Icatibant injection
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date
SYNERGY-NASH results were presented at the European Association for the Study of the Liver Congress 2024 and simultaneously published in The New England Journal of Medicine
New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Largest investment in active pharmaceutical ingredient manufacturing of synthetic medicines in U.S. history
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