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Results For "submission"

315 News Found

Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial
Clinical Trials | May 08, 2026

Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial

NEJM study shows strong protection across strains


Agentic AI poised to reshape pharma operations beyond pilot-stage adoption: Duraisamy Rajan Palani, Founder & CEO, Archimedis Digital
interviews | May 04, 2026

Agentic AI poised to reshape pharma operations beyond pilot-stage adoption: Duraisamy Rajan Palani, Founder & CEO, Archimedis Digital

Enterprise-scale adoption in 2026 will be driven by domain-specific AI, compliance automation, and strong digital foundations across quality, manufacturing and regulatory workflows


FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win
News | May 02, 2026

FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win

The renewal covers two versions of the IQOS device and three HEETS tobacco variants


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


Local manufacturing, deeper CDMO ties, region-specific solutions remain our top priorities in next 3–5 years: Ganesh Bade,  Head Bioprocessing, India, Avantor
interviews | April 24, 2026

Local manufacturing, deeper CDMO ties, region-specific solutions remain our top priorities in next 3–5 years: Ganesh Bade, Head Bioprocessing, India, Avantor

Our company is prioritising deeper collaborations with CDMOs and biosimilar companies as part of its strategy to expand its footprint across India, Middle East, and Africa region


AstraZeneca backs next-gen cardiologists with India Coronary Conquest 2026
Healthcare | April 21, 2026

AstraZeneca backs next-gen cardiologists with India Coronary Conquest 2026

The programme has already drawn over 120 complex percutaneous coronary intervention (PCI) case submissions from across the country


Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic
Drug Approval | April 21, 2026

Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic

OneSource is the contract development and manufacturing organization (CDMO) partner for this product


FDA pushes forward on gene-editing therapies with new safety roadmap
Biotech | April 20, 2026

FDA pushes forward on gene-editing therapies with new safety roadmap

Genome editing holds extraordinary promise for treating previously incurable genetic diseases


Department of Pharmaceuticals seeks proposals for SPEL study to strengthen logistics ecosystem
Supply Chain | April 18, 2026

Department of Pharmaceuticals seeks proposals for SPEL study to strengthen logistics ecosystem

Bidding window open till May 15; study to map costs and bottlenecks across pharma supply chains