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Cholesterol drugs
Merck’s Lipfendra (lipid macrocyclic peptide) became the first oral PCSK9 inhibitor approved by the FDA, expanding the cholesterol-lowering class beyond injectable therapies. The approval marks a...
LDL-lowering approval confirmation
The FDA approval of the first oral PCSK9 inhibitor for adults with high cholesterol underscores accelerating change in how patients may access PCSK9 biology therapeutics. The move comes as the...
Psychiatry M&A and late-stage pipeline expansion
Eli Lilly agreed to acquire AtaiBeckley in a deal worth up to $3.8 billion, seeking to deepen its neuroscience pipeline ahead of Phase 3 momentum in treatment-resistant depression. AtaiBeckley’s...
Oncology regulatory and pipeline update
The FDA approved gedatolisib (Revtorpyk) plus fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, HER2-negative advanced breast cancer without a PIK3CA mutation...
Oncology biomarker testing strategy
Labcorp Oncology’s executives highlighted a shift toward paired germline and somatic testing in oncology, emphasizing how integrated testing can improve access to actionable biomarker insights. In...
Oncology immunotherapy prevention concept
A Johns Hopkins team reported Phase 1 evidence that a peptide-based KRAS-mutant pancreatic cancer vaccine can generate antigen-specific T-cell responses and slow progression of pancreatic lesions...
Cell therapy manufacturing scale-up to GMP
A new focus on scalable cell therapy manufacturing is pushing developers to adopt closed, automated production systems and chemically defined media early—aiming to reduce regulatory friction and...
Pain therapeutics IPO and Nav1.8 competition
Latigo Biotherapeutics filed for an IPO to fund clinical development of a non-opioid pain pipeline built around Nav1.8 inhibition, positioning its oral candidate LTG-001 for Phase 3 studies in...
Women’s oncology market outlook
PwC projected that the women’s oncology market could reach $110 billion by 2030, while warning that funding and care gaps remain. The report highlights structural differences in access and...
Translational immunology and aging pathways
Stanford Medicine researchers linked organ aging to impaired immune clearance, reporting that tissue-resident macrophages fail to clear senescent neutrophils as animals age. In mouse and...
Oral PCSK9 inhibitor approvals expand cholesterol-lowering options
The FDA has approved Merck’s Lipfendra (an oral, macrocyclic peptide) as the first pill in the PCSK9 inhibitor class for adults with high LDL cholesterol. The approval marks a shift from...
Lilly’s acquisition accelerates pharmaceutical push into psychedelics
Eli Lilly agreed to acquire AtaiBeckley in a deal valued at up to $3.8 billion, including $2.8 billion upfront, positioning Lilly to expand its mental health pipeline. AtaiBeckley’s late-stage...
Regulatory expansion in hormone receptor–positive breast cancer targeting PI3K/AKT/mTOR
The FDA approved gedatolisib (Revtorpyk) combined with fulvestrant, with or without palbociclib, for adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a...
Early signals from a KRAS-targeted pancreatic cancer vaccine
Researchers at Johns Hopkins University reported Phase 1 results indicating that a peptide-based vaccine targeting six common mutant KRAS variations can generate protective, antigen-specific...
Scaling cell therapy manufacturing for GMP readiness
A new focus area for cell therapy developers is emerging around shifting manufacturing systems earlier toward GMP-compatible, scalable workflows. The thrust is to transition from research-grade...
Latigo preps IPO to fund Phase 3 path for Nav1.8 pain program
Latigo Biotherapeutics filed for an IPO intended to fund a clinical-stage pipeline of non-opioid pain management drugs, with its oral Nav1.8 inhibitor LTG-001 as the lead spending priority. The...
Testing strategy shift in oncology: paired germline and somatic testing
Labcorp Oncology executives say paired germline and somatic testing is becoming increasingly important in precision oncology, reflecting demand for more complete hereditary and tumor-derived...
Improved immune cell targeting identifies druggable driver of organ aging in preclinical work
Stanford Medicine researchers reported that organ aging in mice and human cells is linked to failure of tissue-resident macrophages to clear senescent neutrophils. In work published in Science,...
Clinical timing matters: immune checkpoint dosing schedule linked to survival
A new analysis in the British Journal of Cancer reports that the timing of immune checkpoint inhibitor dosing can influence overall survival in advanced cancer, based on a large single-center...
GLP-1 access and evidence gaps for older adults under Medicare program
The Trump administration launched a Medicare GLP-1 Bridge program that sets the monthly cost of three weight-loss drugs—Wegovy, tirzepatide (KwikPen Zepbound), and orforglipron (Foundayo)—at $50...