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Results For "US-FDA"

423 News Found

GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push
News | April 30, 2026

GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push

The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need


Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million
R&D | April 30, 2026

Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million

SPARC enters definitive agreement to monetise rare paediatric disease PRV, unlocking capital for R&D and strategic growth


Betting on NK-cell innovation and combination immunotherapy to build global clinical-stage biotech: Dr Maloy Ghosh, CSO, Zumutor Biologics
interviews | April 29, 2026

Betting on NK-cell innovation and combination immunotherapy to build global clinical-stage biotech: Dr Maloy Ghosh, CSO, Zumutor Biologics

Our company remains focused on advancing monoclonal antibody therapeutics for solid tumors, with a clear emphasis on combination immunotherapy strategies


OneSource Pharma, Dr Reddy’s secure Health Canada nod for generic Semaglutide
Drug Approval | April 29, 2026

OneSource Pharma, Dr Reddy’s secure Health Canada nod for generic Semaglutide

Approval for generic Semaglutide Injection strengthens CDMO partnership, enabling scalable supply from OneSource’s US FDA-approved Bengaluru facility


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


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


Aurigene bets big on CRDMO expansion with $100 million outlay
News | April 28, 2026

Aurigene bets big on CRDMO expansion with $100 million outlay

Deploys $40 million in Hyderabad; advances APIs, peptides, and global small molecule capabilities


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


Essilor Stellest lens positioned as key breakthrough in myopia control in India
News | April 28, 2026

Essilor Stellest lens positioned as key breakthrough in myopia control in India

The lens received U.S. Food and Drug Administration (FDA) market authorization via the De Novo pathway in late 2025