Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
Sensorion appointed Fred Chereau chief executive effective June 1, 2026, while reporting six-month Audiogene trial data for SENS-501. The company said early hearing improvements in cohort 2 persisted at six months and no serious adverse events were reported.
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
MSD said sacituzumab tirumotecan improved overall survival and progression-free survival in the Phase III TroFuse-005 trial in endometrial cancer. The study also met its objective response rate endpoint.
The FDA pulled back publication of several studies on COVID-19 and shingles vaccines. The blocked studies involved millions of patient records, and two COVID-19 papers were withdrawn in October 2025.
Regeneron and Parabilis Medicines entered a research collaboration focused on Antibody-Helicon Conjugates. The deal includes $125 million upfront and financing support and up to $2.2 billion in milestones.
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
Drug repurposing expands the therapeutic applications of existing medications, while repositioning examines drugs that never reached market. In neurodegeneration, the approach is described as a pragmatic shortcut into mid- to late-stage trials.
Northeast Florida has moved into Phase III drought conditions, tightening irrigation and other non-essential water uses. Officials cited below-average rainfall, dropping groundwater levels and a rainfall deficit of more than 25 inches year over year.
Baxfendy was approved in the US for hypertension in adults not adequately controlled on other antihypertensive medicines. The approval was based on Phase III BaxHTN results showing significant systolic blood pressure reductions.
Wegovy and Mounjaro prices in South Korea are higher than in China and Japan. South Korea added both drugs to a non-insurance reporting system, but immediate price cuts are unlikely.
Charles River forecast 2026 adjusted EPS of $10.70 to $11.20, above the $10.88 consensus. The company cited improving biotech demand and said Q1 profit will decline in the high-teens.
A real-world analysis found BRAF V600E-mutated papillary thyroid cancer had a proinflammatory molecular profile, but no significant overall survival difference versus BRAF wild-type disease. Treatment choice among BRAF/MEK inhibitors, tyrosine kinase inhibitors, and immunotherapy was not associated with significant survival differences.
People with Down syndrome have a 90% to 95% lifetime risk of Alzheimer’s disease. Amyloid accumulation is almost inevitable by age 40, and baseline assessment is recommended by age 40 with annual follow-up.
Nurix reported new oncology preclinical data at AACR 2026 and outlined progress in its immunology degrader pipeline. The company said NX-3911 could enter an IND this year and Phase 1 data for bexobrutideg are planned this year.
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
Ebola Virus Disease remains a public health concern due to its high fatality rate. A new outbreak has been confirmed in Congo’s Ituri province, while early treatment and approved monoclonal antibodies can enhance survival.
Studies linked better overall brain health, higher midlife vitamin D levels and lifelong intellectual activity with lower Alzheimer’s-related vulnerability. Findings included lower tau pathology, delayed mild cognitive impairment and dementia onset, and higher cognitive resilience.
