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Aug 07, 2026
Moderna posted a narrower-than-expected Q2 loss, with mFLUSIVA awaiting an FDA decision and a Phase 3 norovirus trial missing early success criteria. It reaffirmed 2026 revenue growth and cash guidance.
Jul 16, 2026
FDA approved roflumilast cream 0.3% (Zoryve) for plaque psoriasis in children age 2+, the first once-daily steroid-free topical for that group. A meta-analysis found it improved IGA scores and was well tolerated.
Jul 01, 2026
FDA approved Medtronic's Hugo for urologic procedures; a new robotic and AR system showed high precision in jaw surgery; East and Central Africa saw its first robotic-assisted knee replacements.
Jun 15, 2026
FDA reinstates top vaccines regulator ten days after abrupt departure, drawing criticism from public health experts and far-right commentators. Departure was tied to Duchenne muscular dystrophy treatment and COVID-19 vaccine controversies.
Jun 28, 2026
FDA granted early access to a pancreatic cancer drug; final ARROW data for pralsetinib in RET+ NSCLC were published. A Sarah Cannon Research Institute official outlined a tissue-agnostic vision and highlighted new oncology research.
Aug 05, 2026
Padgett Medical Center offers doctor-supervised compounded semaglutide starting at $149/month for Plant City, FL, with telehealth and statewide shipping. The medication is not FDA-approved.
Jul 27, 2026
KEYNOTE-942 five-year data: intismeran autogene plus Keytruda reduced melanoma recurrence risk by 49% and kept 68.8% of patients cancer-free versus 49.1% with Keytruda alone. Distant metastasis or death risk fell 59%.
Jul 03, 2026
China's 12th national Volume-Based Procurement round places RMB 60 billion across 65 drug varieties, accelerating generics and biosimilars substitution. Separately, Genialis launched BioBridge to help translate Chinese oncology trial results into Western development programs, as Chinese out-licensing hit $137.7 billion in 2025.
Apr 05, 2026
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
Jul 18, 2026
Three infant botulism cases prompted Nara Organics to recall its organic formula. Federal records also show formula makers sent no death reports to the FDA in 26 years, and separate tests found PFAS and patulin.
Apr 10, 2026
Loyal's LOY-002, a daily pill for senior dogs, has cleared two of three FDA requirements for conditional approval. If approved, it would be the first drug for lifespan extension in any species, potentially reaching vets in late 2026.
Apr 28, 2026
Recent Hatch-Waxman decisions address Orange Book delisting, relaxed ANDA pleading standards, and untimely expert invalidity opinions. Courts denied judgment on the pleadings in Rayner Surgical v. Somerset and denied a motion to strike in Harmony Biosciences v. Lupin.
May 03, 2026
A systematic review found strong FAERS signals linking labetalol to rare liver injury, while a case report describes hyperacute liver failure from high-dose atorvastatin that resolved after discontinuation.
Jul 25, 2026
CDC and FDA are investigating a multistate outbreak of drug-resistant Salmonella linked to Rosabella moringa capsules. Seven people in seven states are infected; three hospitalized; no deaths.
Aug 08, 2026
Norton Rose Fulbright expands its pharma and biotech disputes team with February 2026 partner hires. A November 9, 2026 panel will examine shifting patent litigation, including Orange Book, Hatch-Waxman, and BPCIA disputes.
May 15, 2026
EyePoint's DSMC recommended continuing its Phase 3 wet AMD trials without protocol changes after a third review. Topline data for LUGANO are expected mid-2026, with LUCIA shortly after. The company ended 2025 with $300 million in cash and a runway into Q4 2027.
Jul 24, 2026
An ultrasensitive test detects TDP-43 seeds in CSF to diagnose FTLD-TDP. At-home blood tests show promise for remote dementia triage, but primary care use of plasma biomarkers remains limited.
May 31, 2026
Researchers report advances in RNA-based gene therapy: an FDA-approved small molecule modulates RNA splicing, protein-coated nanoparticles enable safer delivery, and a microRNA platform targets glioblastoma.
Mar 11, 2026
Life sciences attorneys will host a March 3 webinar on FDA draft guidances for cell and gene therapies. A March 31 webinar will examine 2026 drug development data from a survey of 150 industry leaders.
Jul 13, 2026
Atezolizumab plus capecitabine showed no significant survival benefit in residual TNBC. Other reports covered HER2-low AR enrichment, first-line ADC choices, and a self-management planner.
