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EU greenlights Sanofi tolebrutinib for secondary progressive MS after FDA rejection
The European Medicines Agency’s CHMP has recommended approval of Sanofi’s BTK inhibitor Cenrifki (tolebrutinib) for a targeted subgroup of patients with non-relapsing secondary progressive...
FDA priority vouchers accelerate psychedelic drug review for depression and PTSD
The FDA has issued priority review vouchers tied to three psychedelic programs, as part of the Trump administration’s push to expand access to mental health treatments. The agency’s announcement...
Regulatory setback in aneurysmal subarachnoid hemorrhage NDA as FDA issues CRL
Grace Therapeutics said the FDA has issued a complete response letter for its GTx-104 NDA, delaying its effort to update the standard of care in aneurysmal subarachnoid hemorrhage. Grace...
Lilly-CureVac-era funding and venture momentum as Kurma closes €215M fund
Kurma Partners has closed its fourth and largest fund, raising €215 million to pursue disruptive therapeutic solutions. The firm’s new vehicle signals continued investor appetite for early- to...
Ray Therapeutics raises $125M Series B to advance optogenetic retinal gene therapy
Ray Therapeutics raised $125 million in a Series B financing to advance its retinal gene therapy platform, including late-stage development and commercial readiness for its lead program RTx-015 in...
Protein engineering and immuno-oncology targeting: cFLIP vulnerability in aggressive DLBCL
Researchers at the University of Cologne’s Center for Molecular Medicine Cologne (CMMC) identified a potential vulnerability in diffuse large B-cell lymphoma (DLBCL), highlighting cFLIP as a...
Cell therapy manufacturing: bioreactor method produces 40M macrophages per week
Hannover Medical School (MHH) reported a scalable method to turn induced pluripotent stem cells into immune-cell factories using medium-sized bioreactors. In Nature Protocols, the team described...
Single-cell cancer risk engineering: microfluidic mechano-NPS predicts breast cancer susceptibility
City of Hope and UC Berkeley researchers reported a microfluidic platform that uses physical stress as a cellular readout of breast cancer risk. In eBioMedicine, the team described...
Advanced imaging expands BBB-capable autophagy enhancer discovery with AI screening
DeepDrugDiscovery unveiled an AI-driven screening platform aimed at finding autophagy enhancers that can penetrate the blood–brain barrier and address Alzheimer’s disease pathology. The approach...
Neural network control improves high-speed nano-positioning precision
Huazhong University of Science and Technology and the University of Victoria reported a neural-network-based switching controller designed to improve precision and responsiveness in high-speed...
EU regulatory approval for Sanofi MS drug after FDA rejection
Sanofi’s tolebrutinib, marketed as Cenrifki for secondary progressive multiple sclerosis, received a positive European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)...
FDA approval of first gene therapy for hearing loss under national priority vouchers
Regeneron won an FDA approval for Otarmeni, a gene therapy targeting a rare inherited form of hearing loss. The approval is notable as the first gene therapy cleared under the agency’s national...
Regulatory setback for Grace Therapeutics’ GTx-104 NDA
Grace Therapeutics said the FDA issued a complete response letter (CRL) for its GTx-104 NDA for aneurysmal subarachnoid hemorrhage, delaying the company’s efforts to update the standard of care....
Sanofi MS turnaround and opposition to FDA clearance
In parallel coverage of Sanofi’s MS regulatory pathway, reporting emphasized that tolebrutinib’s U.S. rejection contrasted with Europe’s momentum. After the FDA returned a complete response...
Securing large financing: Ray Therapeutics’ retinal gene therapy Series B
Ray Therapeutics closed a $125 million Series B financing to advance RTx-015, its optogenetic retinal gene therapy in patients with retinitis pigmentosa. The company said the round funds...
Biomedical VC and growth capital: Kurma closes €215M fund
Kurma Partners announced it has closed its fourth and largest venture fund, raising €215 million, aimed at backing disruptive therapeutic solutions. The fund’s size and track record were...
Oncology diagnostics: Myriad expands MRD approach after AACR readouts
Myriad Genetics is planning a broader Precise MRD launch in breast cancer following AACR readouts. The company’s focus is an ultrasensitive circulating tumor DNA test intended to quantify risk of...
AI-driven clinical trial design: synthetic control arms spotlighted
A Qureight-anchored innovation spotlight highlighted how synthetic control arms—external-data-generated comparators—are being used to reduce dependence on placebo groups. The approach uses...
Cell biology platform: plasma proteomics for Parkinson’s disease classification
Researchers presented a plasma proteomics approach designed to classify Parkinson’s disease using molecular signatures derived from blood. The work, attributed to Minster and Jafri and published...
New FDA approval and generics: regional radiopharma shifts
Novartis’ Pluvicto radioligand therapy faces an EU setback risk after the company withdrew an application to expand the label into earlier prostate cancer treatment, despite having U.S. and UK...