Drug Approval | June 27, 2024
Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
The facility was inspected from May 7 to May 17, 2024
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The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
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
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government
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
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