Drug Approval | June 25, 2024
Lupin receives EIR from US FDA for its Somerset manufacturing facility
The facility was inspected from May 7 to May 17, 2024
The facility was inspected from May 7 to May 17, 2024
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
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
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