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Argo Biopharma to Present Phase II Interim Data on BW-20805 for HAE at AAAAI 2026
Argo Biopharma’s investigational siRNA therapy BW-20805 showed sustained reduction in hereditary angioedema attack rates and plasma prekallikrein levels, with favorable safety, in Phase II interim data selected for AAAAI 2026.
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.
Japan's MHLW accepts GSK's Bepirovisen for Review to Treat Chronic Hepatitis B
Japan’s health ministry has accepted GSK’s new drug application for investigational antisense therapy bepirovirsen, after Phase III trials showed significantly higher functional cure rates in chronic hepatitis B patients.
IISc-Led Pravriddhi Backs Indigenous Compressor Technology for Quality-Critical Industries
Pravriddhi, the pan-India product accelerator led by the Foundation for Science Innovation and Development (FSID) at the Indian Institute of Science (IISc), Bengaluru, has announced the launch of India’s first oil-free water-injected screw compressor, HYDRINO.
Johnson & Johnson Submits sBLA to US FDA for IMAAVY in Warm Autoimmune Hemolytic Anemia
Johnson & Johnson has filed a supplemental biologics application seeking US approval of IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia, a rare disorder with no currently approved treatments.
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.
India and Brazil Explore New Avenues to Strengthen Pharmaceutical Trade
India and Brazil are exploring new opportunities to expand bilateral pharmaceutical trade through enhanced regulatory cooperation and business engagement.
The UK regulator has approved Inluriyo (imlunestrant tosylate) for adults with ER-positive, HER2-negative advanced breast cancer with ESR1 mutations after prior hormone therapy failure.
AS76 Brings Edge AI to Diagnostic Microscopy with On-Device High-Throughput Analysis
SigTuple has launched AS76, an AI-enabled digital morphology analyser designed to automate peripheral blood smear (PBS) microscopic review. The system integrates automated digital microscopy with on-device edge AI computing to deliver faster, standardized results while maintaining strict data privacy.
Lupin Limited Secures US FDA Approval for Generic Brivaracetam Oral Solution
Lupin has received US FDA approval for its generic brivaracetam oral solution, bioequivalent to Briviact, and has launched the product in the US market targeting partial-onset seizures.
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