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Results For "FDA"

2386 News Found

Wanbury's Patalganga site clears Korea FDA inspection with zero observations
Drug Approval | April 30, 2026

Wanbury's Patalganga site clears Korea FDA inspection with zero observations

Patalganga plant received zero observation from USFDA earlier


Solara announces closure of US FDA inspection at Puducherry facility
Drug Approval | April 30, 2026

Solara announces closure of US FDA inspection at Puducherry facility

The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets


AbbVie seeks FDA nod for RINVOQ use in severe alopecia areata
Drug Approval | April 29, 2026

AbbVie seeks FDA nod for RINVOQ use in severe alopecia areata

After Phase 3 results show major hair regrowth gains


FDA okays AstraZeneca’s triple therapy Breztri for asthma
Medical Device | April 29, 2026

FDA okays AstraZeneca’s triple therapy Breztri for asthma

The aim is to simplify and strengthen long-term control of airway disease through triple therapy in one device


Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis
Healthcare | April 29, 2026

Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis

The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder


EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control
Medical Device | April 28, 2026

EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control

The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs


AbbVie seeks FDA nod for subcutaneous SKYRIZI induction in Crohn’s disease
Drug Approval | April 28, 2026

AbbVie seeks FDA nod for subcutaneous SKYRIZI induction in Crohn’s disease

The submission is backed by positive results from the Phase 3 AFFIRM study


Alembic announces FDA final approval for Fingolimod capsules
Drug Approval | April 27, 2026

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)


Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push
Drug Approval | April 27, 2026

Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push

The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA


Philips bags FDA nod for next-gen CT platform
Medical Device | April 24, 2026

Philips bags FDA nod for next-gen CT platform

Aims to boost speed & precision in patient care