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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
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 | 105
Aisa Pharma presented Phase II RECONNOITER trial results showing AISA-021 improved attack-free days and reduced duration of Raynaud’s attacks in systemic sclerosis patients at the World Systemic Sclerosis Congress.
US FDA | 10/03/2026 | By News Bureau
Pfizer Chief Criticises FDA Vaccine Unit Leadership and Decision-Making
Pfizer Chief Executive Officer Albert Bourla has publicly raised concerns about the leadership of the US Food and Drug Administration’s vaccine and biologics division, citing internal discord and recent regulatory decisions as problematic.
US FDA | 03/03/2026 | By Darshana | 131
Johnson & Johnson Submits sBLA to US FDA for IMAAVY in Warm Autoimmune Hemolytic Anemia
Johnson & Johnson has filed a supplemental biologics application seeking US approval of IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia, a rare disorder with no currently approved treatments.
US FDA | 26/02/2026 | By News Bureau | 130
TuHURA Biosciences Files IND for TBS-2025 in Relapsed/Refractory mutNPM1 AML
TuHURA Biosciences has filed an IND with the FDA to evaluate its VISTA-targeting antibody TBS-2025 in combination with a menin inhibitor for relapsed/refractory mutNPM1 AML.
US FDA | 20/02/2026 | By News Bureau | 150
FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in Rare Blood Disorder
US regulator seeks Phase III APOLLO trial results before approving bitopertin for erythropoietic protoporphyria, pushing potential decision until mid-2027.
US FDA | 19/02/2026 | By News Bureau | 102
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