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News about "US FDA "
US Food and Drug Administration Clears Expanded Access Pathway for Daraxonrasib
Regulator issues “safe to proceed” letter to Revolution Medicines, enabling early patient access to investigational therapy for advanced pancreatic cancer.
US FDA | 04/05/2026 | By News Bureau
AstraZeneca Wins US Approval for Self-Administered Saphnelo Pen for Lupus Treatment
AstraZeneca launches a self-injectable version of Saphnelo, offering lupus patients a more convenient treatment option with proven efficacy and safety.
US FDA | 28/04/2026 | By News Bureau
Alembic Pharmaceuticals Secures US FDA Nod for Fingolimod Capsules
Alembic Pharmaceuticals receives US FDA approval for fingolimod capsules, expanding access to a key multiple sclerosis treatment in the US market.
US FDA | 27/04/2026 | By News Bureau
US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation
FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.
US FDA | 23/04/2026 | By News Bureau
Roche Secures FDA Review for Lupus Drug Gazyva
Roche’s Gazyva moves closer to approval for systemic lupus erythematosus after FDA accepts application backed by Phase III trial results showing improved disease control and remission rates.
US FDA | 22/04/2026 | By News Bureau
US Food and Drug Administration Urges Compliance on Clinical Trial Reporting to Address Data Gaps
The US Food and Drug Administration has issued reminders to over 2,200 companies and researchers to submit clinical trial results, aiming to reduce reporting gaps and improve transparency in drug development.
US FDA | 15/04/2026 | By News Bureau
Nuvalent Submits NDA to FDA for Neladalkib in Advanced ALK-Positive Lung Cancer
The investigational ALK inhibitor, backed by Phase I/II trial data, targets treatment-resistant non-small cell lung cancer and has received breakthrough and orphan drug designations.
US FDA | 08/04/2026 | By News Bureau
Denali Therapeutics Wins FDA Approval for AVLAYAH in Hunter Syndrome
US FDA approves Denali Therapeutics’ AVLAYAH for Hunter syndrome (MPS II), the first new treatment in nearly 20 years and a novel biotherapeutic designed to cross the blood-brain barrier.
US FDA | 26/03/2026 | By News Bureau
GSK Secures FDA Approval for Lynavoy, First Treatment for PBC-Related Chronic Itch
FDA approves GSK’s Lynavoy (linerixibat), the first therapy for cholestatic pruritus in primary biliary cholangitis patients, offering significant and sustained itch relief.
US FDA | 21/03/2026 | By News Bureau | 107
US FDA Pushes Shift Away from Animal Testing in Early Drug Studies
The U.S. Food and Drug Administration (FDA) is pushing for a shift away from animal testing in early-stage drug development, encouraging companies to adopt more modern and human-relevant methods.
US FDA | 19/03/2026 | By Darshana | 127
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