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Results For "protocol"

261 News Found

Amgen scores EU nod for UPLIZNA in rare autoimmune disease
News | February 16, 2026

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses


FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue
Drug Approval | February 14, 2026

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”


Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial
Clinical Trials | February 04, 2026

Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial

The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated


Fides launches imaging CRO focused on early-phase clinical decision-making
News | January 30, 2026

Fides launches imaging CRO focused on early-phase clinical decision-making

Fid?s brings core strengths across imaging applications and human biology, supporting work in digestive disease, GI oncology, and select solid tumors


Gradalis’ Vigil therapy dramatically extends survival in advanced ovarian cancer
Clinical Trials | January 17, 2026

Gradalis’ Vigil therapy dramatically extends survival in advanced ovarian cancer

The randomized, double-blind, placebo-controlled Phase 2b VITAL trial enrolled 91 patients with newly diagnosed Stage IIIb–IV epithelial ovarian cancer


AVEO Oncology doses first patient in pioneering AML clinical trial
Clinical Trials | January 16, 2026

AVEO Oncology doses first patient in pioneering AML clinical trial

The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination therapy


FDA rejects Vanda’s jet lag drug in current form
Drug Approval | January 12, 2026

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning


Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery
Drug Approval | January 12, 2026

Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery

The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market


Alkem launches innovative hair growth support therapy kit
News | January 09, 2026

Alkem launches innovative hair growth support therapy kit

The supplements are made using only vegetarian-sourced ingredients


Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader
Opinion | January 07, 2026

Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader

India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry