FDA & Clinical Trials
Iovance Reports 24.6% Response Rate in Lifileucel Lung-Cancer Trial
Iovance Biotherapeutics Inc. (Nasdaq: IOVA) has reported updated Phase 2 results for lifileucel in patients with metastatic non-small-cell lung cancer whose disease progressed following chemotherapy and immune-checkpoint treatment. As of the October 14, 2026 data cutoff, 17 of 69 patients responded to treatment, producing an objective response rate of 24.6%. Fifteen responses were confirmed and…
SELLAS Begins Final Analysis of Phase 3 REGAL AML Trial
SELLAS Life Sciences Group Inc. (Nasdaq: SLS) has started the final analysis of its Phase 3 REGAL trial after the study reached its prespecified 80th event, defined as a patient death. The October 28, 2026, announcement represents an important procedural milestone for the event-driven trial of galinpepimut-S, or GPS, in acute myeloid leukemia. It does…
Beam Reports Initial BEAM-301 Base-Editing Data in GSDIa
Beam Therapeutics Inc. (Nasdaq: BEAM) has reported initial clinical data from its Phase 1/2 trial of BEAM-301, an investigational base-editing treatment for glycogen storage disease type Ia, or GSDIa. The October 27 update included six patients as of the August 17 data cutoff. Three received a 20-milligram dose and three received 40 milligrams, with median…
Cullinan Receives FDA Clearance for Velinotamig Trial
Cullinan Therapeutics Inc. (Nasdaq: CGEM) has received U.S. and Australian regulatory clearance to begin a global Phase 1b/2a trial of velinotamig in adults with relapsing or treatment-resistant autoimmune blood disorders. The open-label, multicenter study will evaluate velinotamig in immune thrombocytopenia, or ITP, and warm autoimmune hemolytic anemia, known as wAIHA. FDA clearance of the Investigational…
FDA Lifts Clinical Hold on Arbutus AB-101 Program
Arbutus Biopharma Corporation (Nasdaq: ABUS) announced on October 22, 2026, that the U.S. Food and Drug Administration has removed the clinical hold on the Investigational New Drug application for AB-101, allowing the company to conduct additional U.S. clinical development of the experimental hepatitis B treatment. The decision removes a regulatory restriction that had remained in…
Cognition Aligns with FDA on Zervimesine Phase 3 Trial
Cognition Therapeutics Inc. (Nasdaq: CGTX) announced on October 22, 2026, that it has reached agreement with the U.S. Food and Drug Administration on key elements of a planned pivotal Phase 3 trial of zervimesine in dementia with Lewy bodies. The discussions addressed patient selection, dosage, treatment duration and clinical endpoints. Cognition plans to enroll patients…
FDA Clears Fresenius multiFiltratePRO for ICU Kidney Care
Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME) has started selling its multiFiltratePRO kidney replacement system to U.S. hospital intensive care units. The launch, announced in a company press release on October 21, 2026, follows FDA action two days earlier on the machine and the two solutions that run through it. The pitch is…
Sun Pharma’s Unloxcyt Wins NCCN Nod in Locally Advanced Skin Cancer
Sun Pharmaceutical Industries’ skin cancer drug Unloxcyt just picked up something that can matter almost as much as an approval: a stronger place in the treatment guidelines U.S. oncologists and insurers actually lean on. On October 20, Sun Pharma (NSE: SUNPHARMA; BSE: 524715) said the National Comprehensive Cancer Network (NCCN) has elevated Unloxcyt (cosibelimab-ipdl) to…
Weekly Obesity Pills From Ascletis Face a Crowded Oral Field
Ascletis Pharma Inc. (Hong Kong Stock Exchange: 1672) wants to turn obesity drugs that normally need a needle into a pill taken once a week. In a press release issued October 19, the company reported new animal data it says supports that goal across five oral peptide programs. The key word is animal. Every number…
Rapport’s RAP-219 Meets Primary Endpoint in Bipolar Mania Trial
Rapport Therapeutics Inc. (Nasdaq: RAPP) announced positive topline results from a Phase 2 clinical trial evaluating RAP-219 in adults experiencing acute mania associated with bipolar I disorder. The randomized, double-blind and placebo-controlled study enrolled 253 adults in the United States. Participants received either 0.75 milligrams of RAP-219 once daily or a placebo for three weeks…
