News about Drug Discovery & Development

Merck reports positive Phase III results for Keytruda and Welireg combination in kidney cancer

Phase III LITESPARK-022 trial shows Keytruda plus Welireg significantly improves disease-free survival in patients with clear cell renal cell carcinoma after surgery, reducing recurrence or death risk by 28 percent.

Drug Discovery & Development | 05/03/2026 | By News Bureau |  192

Ipsen receives positive EMA panel opinion for Ojemda to treat paediatric low-grade glioma

European Medicines Agency’s CHMP recommends conditional approval of Ojemda (tovorafenib) for children with BRAF-altered paediatric low-grade glioma, offering a potential targeted therapy option for relapsed or refractory cases.

Drug Discovery & Development | 05/03/2026 | By News Bureau |  249

EMA Panel Backs Norgine?s XOLREMDI for WHIM Syndrome Under Exceptional Circumstances

The EMA’s CHMP recommends marketing authorisation for XOLREMDI (mavorixafor) to treat WHIM syndrome patients aged 12 and above, marking a major step toward the first licensed therapy for the rare disorder.

Drug Discovery & Development | 03/03/2026 | By News Bureau |  183

XellSmart Secures Fourth FDA and NMPA Clearance for iPSC-Derived Cell Therapy Targeting MSA-P

XellSmart receives US FDA and China NMPA clearance for Phase I/II trials of its iPSC-derived neuron progenitor therapy for MSA-P, expanding its CNS pipeline spanning PD, ALS and spinal cord injury.

Drug Discovery & Development | 03/03/2026 | By News Bureau |  329

Viatris Inc sNDA for MR-141 Accepted by U.S. Food and Drug Administration for Presbyopia Treatment

The US FDA has accepted Viatris’ supplemental application for phentolamine ophthalmic solution 0.75 percent to treat presbyopia and advancing to a potential non-invasive therapy.

Drug Discovery & Development | 02/03/2026 | By News Bureau |  210

Vanda Pharmaceuticals's Imsidolimab BLA Accepted by U.S. Food and Drug Administration for Rare Skin Disease GPP

Vanda’s imsidolimab moves closer to approval as the FDA accepts its BLA for generalised pustular psoriasis, a rare and life-threatening inflammatory skin disorder.

Drug Discovery & Development | 02/03/2026 | By News Bureau |  282

Asahi Kasei Pharma Secures Global License from Alchemedicine to Strengthen Autoimmune Pipeline

Asahi Kasei Pharma has expanded its drug discovery pipeline through an exclusive global licensing agreement with Alchemedicine for novel lead compounds targeting a single, undisclosed mechanism.

Drug Discovery & Development | 27/02/2026 | By Darshana |  248

Mahzi Therapeutics Doses First Patient in Phase I/II Trial of Gene Therapy for Pitt Hopkins Syndrome

Mahzi Therapeutics has dosed the first patient in its global Phase I/II UNITE study evaluating investigational gene therapy MZ-1866 for Pitt Hopkins syndrome, a rare neurogenetic disorder caused by TCF4 mutations.

Drug Discovery & Development | 27/02/2026 | By News Bureau |  304

Hoth Therapeutics Expands Phase IIa CLEER-001 Trial with New Miami Site

Hoth Therapeutics, Inc. has expanded its Phase IIa CLEER-001 trial with a new Miami site after promising interim results for HT-001 in managing skin toxicities linked to EGFR inhibitor cancer therapy.

Drug Discovery & Development | 26/02/2026 | By News Bureau |  167

Bristol Myers Squibb Reports Positive Phase II Data for Reblozyl in Alpha-Thalassemia

Bristol Myers Squibb’s Phase II trial shows Reblozyl significantly improved haemoglobin levels in non-transfusion-dependent patients and reduced transfusion burden in transfusion-dependent alpha-thalassemia, meeting all primary and key secondary endpoints.

Drug Discovery & Development | 25/02/2026 | By News Bureau |  224