News about Drug Discovery & Development

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 |  171

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 |  118

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 |  144

Alembic Pharmaceuticals Wins US FDA Approval for Generic Efinaconazole Topical Solution

Alembic Pharmaceuticals receives US FDA approval for generic efinaconazole topical solution, targeting a US market estimated at USD 500 million.

Drug Discovery & Development | 24/02/2026 | By News Bureau |  219

Advanced Drug Formulation Platform Drives ANZ Licensing Pact Between Formosa and Arrotex

Taiwan-based clinical-stage biotech company Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Arrotex Pharmaceuticals Pty Ltd. for the commercialization of clobetasol propionate ophthalmic suspension 0.05% (APP13007) in Australia and New Zealand.

Drug Discovery & Development | 24/02/2026 | By Darshana |  105

GVRP Partners with Yurogen Biosystems to Advance Biologics Drug Discovery in India

Under this partnership, GVRP will serve as the commercial interface for Yurogen Biosystems in India, enabling streamlined market access, client engagement and programme coordination, while all scientific execution and service delivery will continue to be carried out by Yurogen Biosystems.

Drug Discovery & Development | 23/02/2026 | By News Bureau |  115

CStone Pharmaceuticals Secures UK MHRA Approval for Sugemalimab in Stage III NSCLC

The UK Medicines and Healthcare products Regulatory Agency grants a new indication for sugemalimab monotherapy in unresectable Stage III NSCLC, expanding its European footprint and global commercial reach.

Drug Discovery & Development | 23/02/2026 | By News Bureau |  191

AstraZeneca's Calquence-Venetoclax Regimen Approved in US as First All-Oral Fixed-Duration Therapy for CLL

FDA clears 14-month, chemotherapy-free combination for first-line treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma, backed by positive Phase III AMPLIFY trial data.

Drug Discovery & Development | 23/02/2026 | By News Bureau |  107

Chugai Launches Elevidys Gene Therapy for Duchenne Muscular Dystrophy in Japan

Elevidys receives conditional approval and NHI listing for ambulatory DMD patients aged three to under eight years; launch backed by Phase III EMBARK study and strengthened safety measures.

Drug Discovery & Development | 23/02/2026 | By News Bureau |  163

FDA Approves Vanda Pharmaceuticals' BYSANTI as First-Line Therapy for Bipolar I Disorder and Schizophrenia

BYSANTI (milsaperidone), a new atypical antipsychotic from Vanda Pharmaceuticals, gains FDA approval for acute manic or mixed episodes in bipolar I disorder and schizophrenia in adults, with US launch planned for Q3 2026.

Drug Discovery & Development | 21/02/2026 | By News Bureau |  239