Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA approved Tecentriq and Tecentriq Hybreza for adjuvant muscle-invasive bladder cancer with ctDNA molecular residual disease after cystectomy. The Phase III IMvigor011 study showed a 36% reduction in recurrence or death and a 41% reduction in death.
Benitec Biopharma's gene therapy BB-301 improved swallowing ability in all four OPMD patients followed for at least one year in a Phase Ib/II trial. One patient showed continued improvement at two years. The company plans to meet with the FDA in mid-2026 to discuss a pivotal study.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
A study of over 1.1 million births found a U-shaped relationship between early pregnancy hemoglobin levels and severe neonatal morbidity and mortality, with both anemia and erythrocytosis increasing risk.
Only 17.7% of pediatric anticancer drugs advance to phase 3 trials, and just 12% earn FDA approval within 10 years, compared to 38.7% for adult drugs. The pace of pediatric approvals has accelerated recently, but funding and market size constraints remain.
Nearly 1 in 3 U.S. teens have received a sext and 1 in 4 have sent one, up significantly from 2019. Half of teens who sent a sext later received a sextortion threat, and 47% had their image shared without consent.
Researchers identified the first comprehensive group of human monoclonal antibodies targeting measles virus. The study found antibodies against both H and F proteins, including 4F09, which reduced virus to undetectable levels in an animal model.
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
Vanguard and Goldman Sachs forecasts pointed to stronger long-term returns for international stocks than for U.S. equities. The articles highlighted broad international, European and emerging-market ETFs with low expense ratios and large exposure to non-U.S. markets.
South Africa will begin providing lenacapavir on June 5 after delays tied to postimportation testing, while Uganda has launched rollout of the twice-yearly HIV prevention injection in Lira.
Lilly said a Phase IIIb trial of ixekizumab plus tirzepatide in psoriasis and obesity or overweight beat ixekizumab alone on complete skin clearance plus at least 10% weight loss at 36 weeks.
Alnylam Pharmaceuticals entered a $1.23 billion discovery collaboration with Tenaya Therapeutics to identify up to 15 novel genetic targets for heart disease. The agreement includes $10 million upfront and up to $1.13 billion in milestone payments.
U.S. insulin glargine and biosimilar developments in 2026 included CivicaScript's low-cost launch and California's CalRx rollout. The global insulin biosimilars market reached US$2.5 billion in 2025 and is projected to reach US$6.0 billion by 2033.
CEL-SCI said it expects to begin summer 2026 enrollment in a 212-patient U.S. confirmatory registration study of Multikine in head and neck cancer. The company also said it submitted a Breakthrough Medicine Designation application in Saudi Arabia and reported quarterly net loss of $5.5 million.
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
The FDA cleared neuromodulation devices from Epineuron, Aneuvo and Encora Therapeutics. The products address peripheral nerve surgery, spinal cord injury neurorehabilitation and essential tremor.
Biotech M&A is shifting toward late-stage CNS and oncology assets with human clinical validation. Oncotelic Therapeutics said it advanced global IP protection for OT-101 and CNS drug delivery.
A U.S. appeals court revived Regenxbio’s patent suit against Sarepta, holding the asserted gene-therapy host cell claims are markedly different from anything occurring in nature.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
