News about Drug Discovery & Development

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

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

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

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

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

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 |  113

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

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

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 |  105

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