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Results For "authorization"

350 News Found

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis
News | March 18, 2026

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025


Zuellig Pharma expands Cialis footprint across Asia
News | March 16, 2026

Zuellig Pharma expands Cialis footprint across Asia

The expanded ownership is expected to improve access to Cialis for millions of men in Asia affected by ED and BPH


Veristat expands global trial & regulatory services as Chinese drugmakers push overseas
Clinical Trials | March 14, 2026

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals


Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease
News | March 10, 2026

Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease

The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%


DiaMedica bags Health Canada nod for Phase 2 preeclampsia trial
Clinical Trials | March 09, 2026

DiaMedica bags Health Canada nod for Phase 2 preeclampsia trial

DiaMedica said it plans to launch the trial later in 2026


Moderna wins EU backing for world’s first combined flu-COVID shot
News | March 02, 2026

Moderna wins EU backing for world’s first combined flu-COVID shot

The decision marks a pivotal moment for the Massachusetts-based biotech giant


Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria
Clinical Trials | February 28, 2026

Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria

The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines


ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access
Biotech | February 18, 2026

ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access

The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission


Moderna’s new Covid vaccine mNEXSPIKE wins European approval
News | February 17, 2026

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe


STADA & Bio-Thera bag European nod for Gotenfia
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia