Jun 04, 2026
Diabetes technology companies Dexcom, Insulet, and Sequel/Senseonics announced major product launches and algorithm updates. Dexcom is acquiring Nutrisense and launching an enhanced Stelo app, Insulet is rolling out an updated Omnipod 5 algorithm with lower glucose targets and Abbott compatibility, and Sequel/Senseonics have fully launched the Eversense 365 CGM with the twiist insulin delivery system in the U.S.
Jun 03, 2026
Quantitative and functional MRI techniques are gaining traction as biomarkers in neurodegenerative diseases. A consensus statement provides MRI endpoint recommendations for clinical trials in hereditary ataxias like SCA and Friedreich ataxia. Separately, research shows resting-state fMRI can distinguish subtypes of multiple system atrophy and may improve early diagnosis.
Jun 02, 2026
Recent studies using FDA Adverse Event Reporting System data have identified drug-associated cardiovascular risks, pediatric dry eye, and venlafaxine adverse effects. Findings highlight the importance of pharmacovigilance monitoring.
Jun 02, 2026
The life sciences industry expects strong growth in 2026 driven by AI adoption and GLP-1 drug innovations, but faces headwinds from tariffs, FDA changes, and rising shareholder activism. Over 320 public activist campaigns have targeted life sciences companies since 2020, with 75-80% of biotech and pharma targets being pre-revenue firms.
Jun 02, 2026
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
Jun 02, 2026
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
Jun 01, 2026
The FDA has approved Shionogi's XOCOVA (ensitrelvir) as the first oral antiviral for post-exposure prophylaxis of COVID-19. Approval was based on the Phase 3 SCORPIO-PEP trial, which showed a 67% reduction in risk of symptomatic disease after exposure.
Jun 01, 2026
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
Jun 01, 2026
An experimental pill called daraxonrasib nearly doubled survival for patients with advanced pancreatic cancer in a clinical trial, marking a significant advance for a deadly disease. The drug targets a mutated protein previously considered "undruggable" and reduced the risk of death by 60% compared to chemotherapy.
Jun 01, 2026
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
Jun 01, 2026
Moleculin Biotech's Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia reported a preliminary complete remission rate of approximately 30% and composite remission rate exceeding 40% in the first 45 subjects. The blinded data show a substantial improvement over historical rates with cytarabine alone. The trial is expected to reach its first unblinding milestone in mid-2026.
May 31, 2026
MannKind Corporation announced FDA approval of Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older. The approval makes Afrezza the first needle-free mealtime insulin alternative for children in over 100 years. Eligible patients can access Afrezza for $35 or less per month.
May 31, 2026
The NHS-Galleri trial of the Galleri multi-cancer early detection test did not meet its primary endpoint of reducing combined Stage III-IV cancers. Secondary results showed a 26% reduction in Stage IV diagnoses by the third screening round for 12 deadly cancers. The test increased cancer detection rates four-fold compared to standard screening alone.
May 31, 2026
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
May 30, 2026
The phase 3 ROSELLA trial showed relacorilant plus nab-paclitaxel significantly improved overall survival in platinum-resistant ovarian cancer by 4.1 months versus nab-paclitaxel alone. The benefit was consistent across all subgroups regardless of prior taxane exposure, leading to FDA approval in March 2026. The combination also met its progression-free survival endpoint and demonstrated a favorable safety profile.
May 30, 2026
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
May 30, 2026
GRAIL's NHS-Galleri trial missed its primary endpoint of reducing combined Stage III and IV cancer diagnoses. However, the trial showed a 26% reduction in Stage IV diagnoses by the third screening round. Results were presented at ASCO 2026, and GRAIL stock fell following the announcement.
May 30, 2026
FDA approves MannKind's Afrezza inhaled insulin for children aged 6+ with type 1 and type 2 diabetes. Separately, an updated label provides new starting dose guidance for adults switching from injections or insulin pumps.
May 29, 2026
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
May 29, 2026
GSK's Phase III B-Well trials show bepirovirsen achieved 19% functional cure in chronic hepatitis B, rising to 26% in patients with lower viral activity, versus 0% for placebo. Regulatory decisions are expected in Q3 2026.
