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Results For "FDA"

2061 News Found

UFlex introduces FSSAI compliant single-pellet solution for food packaging
Packaging | June 20, 2025

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials


Briefs: Hikal and Sun Pharma
Drug Approval | June 17, 2025

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility


Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa
Drug Approval | June 12, 2025

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar


Allarity announces enrolment of first patient in phase 2 clinical trial protocol of Stenoparib in advanced ovarian cancer
Clinical Trials | June 05, 2025

Allarity announces enrolment of first patient in phase 2 clinical trial protocol of Stenoparib in advanced ovarian cancer

The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval


Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer
Clinical Trials | June 02, 2025

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer

Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer


Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC
Clinical Trials | June 02, 2025

Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC

First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC


Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows
News | June 02, 2025

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows


Pfizer’s Braftovi combination regime reduces death risk  for patients with  BRAF V600E mutant mCRC
Clinical Trials | May 31, 2025

Pfizer’s Braftovi combination regime reduces death risk for patients with BRAF V600E mutant mCRC

Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment


Granules India posts Q4 FY25 PAT at Rs. 152 Cr
News | May 28, 2025

Granules India posts Q4 FY25 PAT at Rs. 152 Cr

The company reported sustained increase in formulations' share despite slowdown in productivity of Gagillapur facility