News about Drug Discovery & Development

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.

Drug Discovery & Development | 10/03/2026 | By News Bureau |  109

Insilico Medicine's AI-Discovered CKD Anemia Drug ISM4808 Enters Phase I Trial Under TaiGen Biotechnology Partnership

TaiGen Biotechnology doses first participant in Phase I trial of ISM4808, an AI-designed oral therapy from Insilico Medicine for chronic kidney disease-related anemia.

Drug Discovery & Development | 09/03/2026 | By News Bureau |  173

U.S. Food and Drug Administration Approves Tec-Dara Combination Therapy for Relapsed Multiple Myeloma

U.S. Food and Drug Administration grants rapid approval to Tec-Dara, a combination of teclistamab and daratumumab hyaluronidase-fihj, for adults with relapsed or refractory multiple myeloma after at least one prior therapy.

Drug Discovery & Development | 07/03/2026 | By News Bureau

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 |  118

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 |  186

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 |  125

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 |  178

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 |  103

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 |  151

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 |  160