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Aug 08, 2026
New research highlights strategies to overcome cancer drug resistance: a triple-drug AML combination, a breast cancer resistance target, evolutionary treatment switching, DNA damage mechanisms, and sildenafil's anti-metastatic potential.
May 17, 2026
Tracy Beth Hoeg, the FDA's acting drug center director, has been removed from her role after leading reviews of antidepressants, COVID-19 vaccines and RSV drugs. She is replaced by Dr. Mike Davis, as the agency continues a leadership shake-up.
Mar 18, 2026
Candel Therapeutics secured $100M royalty funding for CAN-2409 and plans a Q4 2026 BLA submission in prostate cancer. Updated NSCLC phase 2a data showed median overall survival of 25.4 months, with a phase 3 trial planned for Q2 2026.
Jun 09, 2026
ADARx will present onvuzosiran Phase 1/2 data and Phase 3 STOP-HAE design at AAAAI and EAACI 2026. The investigational siRNA for hereditary angioedema has FDA Orphan Drug Designation.
Jul 01, 2026
Cadrenal Therapeutics received FDA guidance for a pivotal Phase 3 trial of CAD-1005 in HIT after an End-of-Phase 2 meeting. Phase 2 data showed a >25% absolute reduction in thrombotic events. The company also plans a Phase 2a trial in cardiac surgery-associated AKI.
Aug 07, 2026
Biotechnology is now a national security issue in Washington, with investment restrictions, export controls, and procurement bans targeting China. The Pentagon designated WuXi AppTec as a Chinese military company, sparking a legal challenge. Policymakers also warn about supply chain dependence, biosecurity, and the dual-use dilemma.
Jul 29, 2026
FDA granted rolling review for Palvella's QTORIN rapamycin NDA. Also covered: global expedited approval pathways, accelerated approval scrutiny, and multi-regional CDx strategies.
Aug 02, 2026
A major clinical trial found that Grail's Galleri blood test did not reduce late-stage cancer diagnoses, raising questions about multi-cancer early detection. Meanwhile, the FDA approved a second blood-based colorectal cancer screening test, and an AI-powered liquid biopsy showed promise for Ewing sarcoma.
Aug 08, 2026
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
Jul 01, 2026
PureTech Health's IPF drug deupirfenidone received orphan drug designation from the FDA and European Commission. The designation provides market exclusivity and financial incentives. A phase 3 trial is expected to begin in the first half of 2026.
Jul 08, 2026
Daraxonrasib reduced death risk by 60% versus chemo in Phase 3 pancreatic cancer trial (median OS 13.2 vs 6.7 months). EMA began rolling review; zoldonrasib combo data presented at ESMO GI.
Jul 15, 2026
The FDA now defaults to a single pivotal trial for drug approvals, replacing the two-trial standard. Critics warn it could approve ineffective drugs. A draft guidance covers individualized therapies.
May 18, 2026
US FDA approved Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen for adults with chronic lymphocytic leukaemia and small lymphocytic lymphoma. Approval based on AMPLIFY phase III trial showing 77% progression-free at three years vs 67% with chemoimmunotherapy. Regimen already cleared in EU, UK, and Canada.
Aug 05, 2026
Biotech funding roundup: $8M CIRM grant to Siren, $3.5M pre-seed for Claryx, Syntax Bio's $14.4M Series A, €80M Novo Nordisk Foundation programme, and Appili's NIAID contract termination.
Jul 02, 2026
Telix gained FDA alignment to advance ProstACT Global Phase 3 into U.S. Part 2 for TLX591-Tx in mCRPC, with safety data from Part 1 deemed sufficient. The trial will combine the therapy with abiraterone, enzalutamide, or docetaxel, pending IND amendment review.
Jun 18, 2026
The FDA has accepted Gilead's New Drug Application for the investigational once-daily HIV regimen bictegravir/lenacapavir and granted priority review, with a PDUFA action date of August 27, 2026. The filing is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 data showing comparable efficacy in maintaining virological suppression. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment.
Jul 31, 2026
Relay Therapeutics reported Q4/FY 2025 results, outlined 2026 milestones for zovegalisib, and held ~$555M in cash. Initial vascular anomaly data and breast cancer triplet data are expected in 2026.
Jul 27, 2026
FDA approved AstraZeneca's Breztri Aerosphere for asthma; EU CHMP recommended Trixeo. Phase 3 KALOS/LOGOS trials showed improved lung function and reduced severe exacerbations versus dual therapy.
Jul 02, 2026
Recent studies applied HPLC-QTOF-MS/MS and LC-MS/MS to profile lichen metabolites, optimize CYP assay buffer conditions, and quantify tramadol and dexketoprofen in rat plasma, expanding the scope of pharmaceutical analysis.
Jul 15, 2026
Researchers at MD Anderson developed an extracellular vesicle-based platform that delivers full-length DMD mRNA, restoring dystrophin production and improving muscle function in preclinical Duchenne muscular dystrophy models. The study, published in Nature Biomedical Engineering, showed reduced side effects compared with viral gene therapies.
