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FDA approvals – multiple myeloma protein degrader debut
The FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj plus dexamethasone for adults with advanced multiple...
Capricor – Duchenne cell therapy BLA pathway shifts after FDA open-label results
Capricor Therapeutics’ deramiocel program is getting renewed attention after the company reported open-label extension (OLE) data linked to its Duchenne muscular dystrophy (DMD) filing pathway...
Biogen – first China approval for multiple myeloma monoclonal antibody
Biogen secured its first global approval in China for felzartamab, approving the monoclonal antibody for treatment of second-line multiple myeloma alongside lenalidomide and dexamethasone. The...
FDA submission setback – OraSure pulls CT/NG submission tied to Sherlock milestone payments
OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for its InteliQuick CT/NG point-of-care molecular test after discussions with the agency, pushing clearance beyond the...
Corporate finance – silence therapeutics upsized funding for siRNA pipeline after Phase 2 win
Silence Therapeutics priced an upsized public offering expected to raise about $175 million, aiming to fund its short interfering RNA programs, including divesiran after the drug achieved a...
Company funding/launch – Boulevard emerges from stealth with $65M for quarterly autoimmune antibodies
Boulevard Bio exited stealth with about $65 million in launch financing, backed entirely by Deerfield Management and its affiliates, to build B cell-directed therapies for autoimmune disease. The...
Clinical research – Theta-rhythm stimulation shows cognitive benefit in Parkinson’s impairment
Researchers reported that tuning deep-brain stimulation to the brain’s theta rhythm improved cognitive performance in Parkinson’s patients with cognitive impairment. The finding challenges the...
Cancer immunology – PHGDH blockade reverses dabrafenib resistance in BRAF V600E anaplastic thyroid cancer
A study published in Cell Death Discovery reports that blocking PHGDH can overcome resistance to dabrafenib in BRAF V600E anaplastic thyroid carcinoma by driving metabolic rewiring. The work by...
Genomics/dx – Proteotype launches clinical studies to support CE-IVDR filing for Enlighten MCED test
Proteotype Diagnostics announced a new clinical study planned for Enlighten, its multicancer early detection test, to support CE-IVDR submission. The company is also initiating a separate study to...
Bio manufacturing/tech shift – Merger-backed public platform moves into fibrosis pipeline with $125M
Skye Bioscience and Redx Pharma agreed to combine, creating a new public company, Fibrx Therapeutics, with about $125 million in financing to advance fibrotic disease assets. The deal follows...
Regulatory approvals in oncology
Bristol Myers Squibb won FDA accelerated approval for iberdomide (Zenbexus) in multiple myeloma, marking both the FDA’s nod for a CELMoD and an expansion of the company’s second-line regimen...
China regulatory greenlights for oncology and diagnostics
Biogen’s felzartamab received its first global approval in China for the treatment of multiple myeloma, extending the drug’s availability alongside standard backbones. The approval targets...
Carve-outs, licensing, and deals reshaping rare-disease gene therapy portfolios
PTC Therapeutics outbid rivals in a bankruptcy auction to acquire Sangamo’s ST-920 (isaralgagene civaparvovec) gene therapy for Fabry disease. Under the deal terms, Sangamo will receive $111...
CAR-T and advanced cell therapy evolution in oncology
A new study reports a strategy to strengthen CAR-T cells against solid tumors by redesigning how the engineered T cells operate in the tumor environment. The work focuses on overcoming two...
Duchenne muscular dystrophy: FDA pathway maneuver for deramiocel
Capricor Therapeutics moved to salvage its deramiocel FDA filing after a negative advisory committee outcome by planning to amend the BLA and seek reconsideration focused on an updated DMD...
Late-stage diabetes and obesity therapeutics: market access and policy pressure
Eli Lilly is stepping up enforcement against black-market retatrutide diversion in California, signaling that supply security and compliance are becoming central to GLP-1-era pricing and access...
Biotech funding and launch financing
Boulevard Bio emerged from stealth mode with $65 million in launch financing from Deerfield Management, debuting multi-specific antibodies aimed at B cell-driven autoimmune diseases. The company...
Capital markets and corporate finance for life science tools
Illumina moved to reinforce its balance sheet and refinance near-term obligations by entering a $1 billion credit facility with Bank of America and simultaneously arranging a $300 million note...
Clinical development setbacks and adjustments in respiratory oncology
Taiho Oncology and Cullinan Therapeutics reported positive Phase 3 data for zipalertinib plus chemotherapy in frontline lung cancer with EGFR exon 20 insertion mutations, with investigators...
Next-generation analytics: liquid biopsy and companion diagnostics platform progress
Proteotype Diagnostics is advancing its Enlighten multicancer early detection test toward clinical deployment with new studies intended to support CE-IVDR submission pathways. The company is...