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Results For "clinical-data"

188 News Found

FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19
Drug Approval | August 31, 2025

FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19

Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season


Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
News | August 29, 2025

Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial

Triggering global regulatory submissions this year for the treatment of obesity


Vertex faces regulatory delays for Journavx and reports VX-993 Phase 2 trial failure
News | August 06, 2025

Vertex faces regulatory delays for Journavx and reports VX-993 Phase 2 trial failure

Treatment with the selective NaV1.8 pain signal inhibitor VX-993 after bunionectomy surgery did not meet the primary endpoint


EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1
News | July 27, 2025

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision


ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia
Clinical Trials | July 21, 2025

ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials


Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint
Clinical Trials | July 21, 2025

Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint

The INSPIRE-1 and INSPIRE-2 trials are Phase 3 studies assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis (PsA)


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


Merck to present new research data across its HIV prevention and treatment pipeline at IAS 2025
Clinical Trials | July 09, 2025

Merck to present new research data across its HIV prevention and treatment pipeline at IAS 2025

Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment


Everest Medicines progresses in AI-powered mRNA platform at 2025 R&D day
News | July 08, 2025

Everest Medicines progresses in AI-powered mRNA platform at 2025 R&D day

The company showcased three core programs developed through this platform