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Results For "ANDA"

3104 News Found

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer
Clinical Trials | December 29, 2025

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38


Govt cancels registration of popular cosmetic product over misleading claims
Policy | December 29, 2025

Govt cancels registration of popular cosmetic product over misleading claims

The cancellation underscores the regulator’s strict stance against misleading cosmetic claims


Nona Biosciences expands platform to accelerate early clinical trials
Biotech | December 27, 2025

Nona Biosciences expands platform to accelerate early clinical trials

Nona aims to help global biopharmaceutical companies fast-track clinical trial initiation without compromising scientific rigor or quality standards


Health Minister Nadda to launch Indian Pharmacopoeia 2026 in the first week of Jan. 2026
News | December 27, 2025

Health Minister Nadda to launch Indian Pharmacopoeia 2026 in the first week of Jan. 2026

Indian Pharmacopoeia is now recognised in 19 countries, reflecting growing international confidence in India’s regulatory and scientific capabilities


Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio
News | December 26, 2025

Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio

The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies


Cipla launches needle-free inhalable insulin Afrezza in India
News | December 26, 2025

Cipla launches needle-free inhalable insulin Afrezza in India

Afrezza comes in single-use cartridges, delivered via a simple inhaler device. Users select the appropriate cartridge, load it, inhale the insulin, and remove the cartridge


Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer
Clinical Trials | December 25, 2025

Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer

Study published in laboratory investigation, the official journal of the United States and Canadian Academy of Pathology