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Tangram seeks MHRA clearance: TGM‑312 head‑to‑head for MASH
Tangram Therapeutics submitted a clinical trial application to the U.K. Medicines and Healthcare products Regulatory Agency to initiate a Phase I/II study of TGM‑312 for metabolic...
Aspen raises $115m—scales iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to accelerate clinical development and manufacturing scale-up of ANPD001, its autologous iPSC-derived cell therapy for Parkinson’s disease. The...
FDA approves Voyxact: first APRIL blocker for IgA nephropathy
The U.S. FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary IgA nephropathy to reduce proteinuria. Approval was supported by interim results from the...
CMS sets 2027 Medicare prices—semaglutide among steep cuts
CMS published final negotiated Medicare prices for the second round under the Inflation Reduction Act, cutting prices on 15 high‑expenditure drugs slated to take effect in 2027. The list includes...
FDA proposes reclassifying companion diagnostics: 510(k) route suggested
The FDA issued a proposal to reclassify certain nucleic acid‑based companion diagnostic devices from Class III (PMA) to Class II with special controls, opening the 510(k) pathway for tests tied to...
Tangram seeks MHRA clearance for TGM‑312 in MASH trials
Tangram Therapeutics submitted a clinical trial application to the U.K. MHRA to initiate a Phase I/II study of TGM‑312 for metabolic dysfunction‑associated steatohepatitis (MASH). The CTA filing...
China clears CSPC’s JMT‑206 to enter obesity trials
China’s NMPA granted clinical trial clearance to CSPC Pharmaceutical Group for JMT‑206, a weight‑management candidate for people with obesity or overweight and at least one weight‑related...
SK Biopharma licenses preclinical radiopharmaceutical WT‑7695 from WARF
SK Biopharmaceuticals acquired exclusive worldwide rights from the Wisconsin Alumni Research Foundation (WARF) to develop, manufacture and commercialize WT‑7695, a preclinical radiopharmaceutical...
Vigencell’s antigen‑specific T cells hit phase II endpoint—Korea filing planned
Vigencell reported positive top‑line phase II results for VT‑EBV‑N, an antigen‑specific cytotoxic T‑cell therapy for natural killer T‑cell lymphoma (NKTCL), and intends to seek conditional...
Allogeneic iPSC‑derived iNKT cells enter clinic for recurrent head and neck cancer
A phase I trial tested allogeneic induced pluripotent stem cell (iPSC)‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer, marking a translational step...
Robust WGS from FFPE tissue unlocks clinical‑grade oncology sequencing
Researchers published a validated methodology that enables whole‑genome sequencing (WGS) from formalin‑fixed paraffin‑embedded (FFPE) tumor specimens, overcoming historical technical challenges...
Aspen raises $115M – scales iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to accelerate clinical development and manufacturing of its autologous iPSC-derived cell therapy ANPD001 for Parkinson’s disease. The financing...
FDA clears Otsuka’s Voyxact: first APRIL inhibitor for IgAN
The U.S. Food and Drug Administration granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact), a humanized monoclonal antibody targeting APRIL, for adults with primary immunoglobulin A...
Medicare price cuts land: CMS sets 2027 negotiated rates – semaglutide included
The Centers for Medicare & Medicaid Services finalized negotiated Medicare prices for 15 drugs under the Inflation Reduction Act, including semaglutide — the active ingredient in Novo Nordisk’s...
FDA delays Ascendis decision – three‑month review on TransCon CNP
The FDA extended its review of Ascendis Pharma’s TransCon CNP for achondroplasia by three months, citing the need to evaluate recently submitted information related to the treatment’s...
Allogeneic iPSC‑derived iNKT cells tested in recurrent head‑and‑neck cancer
A phase 1 clinical trial tested allogeneic induced pluripotent stem cell (iPSC)‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer, reporting early...
Vigencell’s VT‑EBV‑N meets phase II endpoint – firm eyes conditional approval in South Korea
Vigencell announced positive top‑line results from a Phase II study of VT‑EBV‑N, an antigen‑specific killer T‑cell therapy targeting Epstein‑Barr virus‑associated natural killer T‑cell lymphoma...
In vivo gene editing pushes forward – delivery and timing remain the bottlenecks
Two complementary reports spotlight advances and challenges in translating gene editing to in vivo and prenatal settings. One review describes the field’s push from ex vivo to in vivo approaches...
mRNA peptibodies eradicate MDR pneumonia in mice – new delivery approach
A Nature Biotechnology paper reported that antimicrobial peptides encoded as mRNA 'peptibodies' and delivered to mouse lungs in anti‑inflammatory lipid formulations eradicated multidrug‑resistant...
FDA proposes reclassifying companion diagnostics to Class II – 510(k) route eyed
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostics used with approved oncology therapeutics from Class III (PMA) to Class II (special controls), which would allow...