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🇺🇸 FDA
Palvella Therapeutics Begins Phase 2 Trial of QTORIN Rapamycin for Rare Angiokeratomas
NewsMay 5, 2026

Palvella Therapeutics Begins Phase 2 Trial of QTORIN Rapamycin for Rare Angiokeratomas

Palvella Therapeutics doses first patients in Phase 2 LOTU trial of QTORIN rapamycin for angiokeratomas, targeting over 50,000 US patients with no approved treatments.

Michael Rivera
Neurocrine Biosciences Begins Phase 1 Trial of NBIP-2118 for Obesity Treatment
NewsMay 5, 2026

Neurocrine Biosciences Begins Phase 1 Trial of NBIP-2118 for Obesity Treatment

Neurocrine Biosciences initiates first-in-human Phase 1 trial for NBIP-2118, a novel CRF2 receptor agonist targeting obesity through non-incretin mechanisms.

Dr. Natalie Hughes
CAPLYTA (Lumateperone) Ranks Highest Among FDA-Approved Adjunctive Depression Treatments in Network Meta-Analysis
NewsMay 5, 2026

CAPLYTA (Lumateperone) Ranks Highest Among FDA-Approved Adjunctive Depression Treatments in Network Meta-Analysis

New network meta-analysis shows CAPLYTA demonstrated superior efficacy across four key measures compared to other FDA-approved adjunctive MDD therapies.

Dr. Sarah Mitchell
Cellenkos Receives FDA Clearance for CK0802 Phase 2a Trial in Steroid-Refractory GVHD
NewsMay 5, 2026

Cellenkos Receives FDA Clearance for CK0802 Phase 2a Trial in Steroid-Refractory GVHD

Cellenkos gets FDA approval to test CK0802, a first-in-class regulatory T cell therapy for patients with steroid-refractory graft-versus-host disease.

Dr. Priya Nandakumar
Cellenkos Receives FDA Clearance for CK0802 Phase 1b/2a Trial in Steroid-Refractory GVHD
NewsMay 5, 2026

Cellenkos Receives FDA Clearance for CK0802 Phase 1b/2a Trial in Steroid-Refractory GVHD

Cellenkos gets FDA clearance for CK0802 Phase 1b/2a trial targeting steroid-refractory graft-versus-host disease with first-in-class Treg therapy.

James Chen, PharmD
Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026
NewsPancreatic CancerMay 4, 2026

Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026

Alpha Tau reports 100% local disease control with Alpha DaRT in pancreatic cancer trials, showing favorable safety profile in 26 patients at DDW 2026.

Dr. Sarah Mitchell
Takeda's TAK-881 Shows Positive Phase 2/3 Results for Primary Immunodeficiency Disease Treatment
NewsMay 4, 2026

Takeda's TAK-881 Shows Positive Phase 2/3 Results for Primary Immunodeficiency Disease Treatment

Takeda announces positive topline results for TAK-881 in pivotal Phase 2/3 trial, showing comparable efficacy to HYQVIA with reduced infusion time for PID patients.

Dr. Laura Bennett
InspireMD Receives FDA Approval for SwitchGuard Neuro Protection System CGUARDIANS III Pivotal Trial
NewsMay 4, 2026

InspireMD Receives FDA Approval for SwitchGuard Neuro Protection System CGUARDIANS III Pivotal Trial

InspireMD secures FDA IDE approval for CGUARDIANS III pivotal study of SwitchGuard Neuro Protection System, advancing stroke prevention technology development.

Dr. Natalie Hughes
mBIOTA Elemental Diet Shows Promise for IBS Treatment in New Clinical Trial Data Presented at DDW 2026
NewsMay 4, 2026

mBIOTA Elemental Diet Shows Promise for IBS Treatment in New Clinical Trial Data Presented at DDW 2026

New clinical trial data validates mBIOTA Elemental as effective IBS therapeutic, showing symptom improvement across all three IBS subtypes at DDW 2026.

Dr. Sarah Mitchell
Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026
NewsPancreatic Cancer/OncologyMay 4, 2026

Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026

Alpha Tau reports 100% local disease control with Alpha DaRT device in heavily pre-treated pancreatic cancer patients with favorable safety profile.

Dr. Laura Bennett
Cytokinetics to Report Aficamten Phase 3 Trial Results for Non-Obstructive Hypertrophic Cardiomyopathy May 5, 2026
NewsMay 4, 2026

Cytokinetics to Report Aficamten Phase 3 Trial Results for Non-Obstructive Hypertrophic Cardiomyopathy May 5, 2026

Cytokinetics announces topline results from pivotal ACACIA-HCM Phase 3 trial of aficamten for non-obstructive hypertrophic cardiomyopathy on May 5, 2026.

Dr. Sarah Mitchell
Akebia Therapeutics Vadadustat Shows Significant Mortality Reduction in New Kidney Disease Analysis
NewsMay 4, 2026

Akebia Therapeutics Vadadustat Shows Significant Mortality Reduction in New Kidney Disease Analysis

Akebia Therapeutics announces Vadadustat post-hoc analysis published in JASN shows statistically significant reduction in mortality and hospitalization for kidney disease patients.

Dr. Natalie Hughes