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Results For "NDA"

4491 News Found

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial
Clinical Trials | November 21, 2025

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration


FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
Drug Approval | November 21, 2025

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options


AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
Drug Approval | November 21, 2025

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study


BPL Medical Technologies brings next-gen Korean ultrasound to India
Medical Device | November 21, 2025

BPL Medical Technologies brings next-gen Korean ultrasound to India

The X CUBE 50 integrates ALPINION’s advanced X+ Architecture


Merck’s two-drug HIV regimen hits phase 3 success
Clinical Trials | November 21, 2025

Merck’s two-drug HIV regimen hits phase 3 success

The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks


Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment
Drug Approval | November 21, 2025

Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment

This is the first and only subcutaneous immune checkpoint inhibitor available in Europe


Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification
News | November 21, 2025

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub


EMA launches streamlined process to fast-track critical medicines, vaccines
News | November 21, 2025

EMA launches streamlined process to fast-track critical medicines, vaccines

The move is expected to be crucial during health crises