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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
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 | 121
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 | 100
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 | 127
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
Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.
US FDA | 19/02/2026 | By News Bureau
CStone's CS2009 Secures U.S. FDA IND Clearance for Phase II Trial in Advanced Solid Tumours
CStone Pharmaceuticals has received U.S. FDA IND clearance to begin a Phase II trial of its trispecific antibody CS2009 for advanced solid tumours, advancing its global immunotherapy development programme.
US FDA | 16/02/2026 | By News Bureau
Takeda's Oveporexton NDA Accepted by US FDA with Priority Review for Narcolepsy Type 1
FDA grants Priority Review to Takeda’s investigational orexin receptor agonist oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA decision expected in Q3 this year.
US FDA | 11/02/2026 | By News Bureau | 104
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