News about Drug Discovery & Development

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 |  384

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 |  153

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 |  200

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 |  278

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 |  264

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 |  341

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 |  386

Shield Therapeutics' ACCRUFeR Becomes First FDA-Approved Oral Iron Therapy for Children Aged 10 and Above

Shield Therapeutics secures expanded U.S. Food and Drug Administration approval for ACCRUFeR (ferric maltol) to treat iron deficiency in pediatric patients aged 10 and above, addressing a major unmet need.

Drug Discovery & Development | 20/02/2026 | By News Bureau |  200

GRAIL Reports Topline Results from NHS-Galleri Trial of Multi-Cancer Early Detection Test

Results from the NHS-Galleri trial show that annual multi-cancer screening with the Galleri test reduced Stage IV diagnoses and significantly increased early cancer detection across England’s NHS population.

Drug Discovery & Development | 20/02/2026 | By News Bureau |  427

Merck and Mayo Clinic Partner to Accelerate AI-Driven Drug Discovery and Development

Merck, known as MSD outside the United States and Canada, has entered into a strategic research and development agreement with Mayo Clinic, one of the world’s leading hospital systems, to advance the use of artificial intelligence (AI), advanced analytics and multimodal clinical data in drug discovery and development.

Drug Discovery & Development | 20/02/2026 | By Darshana |  151