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Results For "ANDA"

3105 News Found

APL Healthcare’s Unit-IV classified as VAI by the USFDA
News | March 14, 2026

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed


Co-Diagnostics bags key Japanese patent, bolstering global push for rapid PCR testing
News | March 14, 2026

Co-Diagnostics bags key Japanese patent, bolstering global push for rapid PCR testing

The Japan Patent Office is considered one of the world's most rigorous and meticulous in its review process


FDA nod to LifeVac De Novo, paving for next-generation anti-choking device
Medical Device | March 12, 2026

FDA nod to LifeVac De Novo, paving for next-generation anti-choking device

The FDA classified LifeVac as a Class II medical device


Vertex Pharmaceuticals’ new kidney drug shows dramatic results in Phase 3 trial
Clinical Trials | March 12, 2026

Vertex Pharmaceuticals’ new kidney drug shows dramatic results in Phase 3 trial

The trial met its primary endpoint, with patients receiving povetacicept achieving a 52.0% reduction in UPCR at Week 36


FDA nod to first treatment for rare genetic brain disorder
Drug Approval | March 12, 2026

FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature


Kainova reports positive Phase I results for receptor antagonist targeting advanced tumors
Clinical Trials | March 12, 2026

Kainova reports positive Phase I results for receptor antagonist targeting advanced tumors

Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile


Alcon launches Hydrus Microstent in India to transform glaucoma care
News | March 11, 2026

Alcon launches Hydrus Microstent in India to transform glaucoma care

The Hydrus Microstent stands out as the first and only MIGS device backed by five-year clinical outcomes


Roche reports Phase III persevERA breast cancer trial results
Clinical Trials | March 11, 2026

Roche reports Phase III persevERA breast cancer trial results

Giredestrant shows promise despite missing primary goal


Pfizer’s experimental atopic dermatitis drug shows strong Phase 2 results
Clinical Trials | March 11, 2026

Pfizer’s experimental atopic dermatitis drug shows strong Phase 2 results

The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75