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Jun 23, 2026
FDA Commissioner Marty Makary resigned on May 12, 2026, after a 13-month tenure, leaving many informal policy initiatives vulnerable to reversal. Acting Commissioner Kyle Diamantas now leads the agency amid leadership turnover and industry calls for stability.
Jul 29, 2026
Candel initiated the Phase 3 AURORA trial of aglatimagene in NSCLC and plans a Q4 2026 BLA in localized prostate cancer, with a potential 2027 launch. The company also appointed a Chief Commercial Officer.
Jul 21, 2026
Helus completed Phase 3 enrollment for HLP003 in depression; data due Q4 2026. Compass is on track for COMP360's NDA, and an ayahuasca ingredient showed promise in a phase 2a trial.
Apr 28, 2026
A multistate outbreak of highly drug-resistant Salmonella has been linked to moringa powder capsules, with seven infections across seven states. Three people have been hospitalized, and Ambrosia Brands, LLC has voluntarily recalled specific lots of Rosabella-brand moringa capsules.
Jul 21, 2026
FDA approved zenocutuzumab-zbco (Bizengri) for NRG1 fusion-positive cholangiocarcinoma on May 8, 2026. The eNRGy trial showed a 36.8% ORR. It also received priority review, breakthrough, and orphan designations.
Aug 08, 2026
Clinical trials show a pancreatic cancer drug nearly doubles survival, a head-and-neck therapy shrinks tumors, and new research explains drug resistance. Cancer mortality is falling in the US and UK.
Jun 06, 2026
Animal biologics in the U.S. are regulated by USDA, not FDA. Licensure requires proof of purity, safety, potency, and efficacy. Unlike the UK and EU, no approval pathway for animal biosimilars exists.
Aug 06, 2026
Insmed reported Q2 2026 revenues of $425.5M, with BRINSUPRI at $309.2M. It raised 2026 BRINSUPRI guidance to $1.25B-$1.40B and lifted peak revenue estimates for its lead programs to over $14B.
Aug 07, 2026
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
Jul 19, 2026
Amgen detailed its T-cell engager and precision therapy strategy at Citi's 2026 summit. GT Biopharma, Onco-Innovations, Oncotelic, and Samsung Biologics also advanced AI and organoid platforms in drug development.
May 07, 2026
Alzheimer's blood tests are gaining FDA clearances and strong patient interest, yet surveys show clinicians remain skeptical about their reliability and clinical benefit. A UK survey found fewer than one-third of psychiatrists have used biomarkers, while only 6% of memory services meet access guidelines. An ethical framework urges careful implementation, especially in primary care.
Jun 19, 2026
FDA's vaccine advisory committee unanimously recommended Moderna's mRNA flu vaccine mFlusiva for adults 50 and over, the committee's first new vaccine review since 2023. The FDA expects an approval decision by Aug 5, 2026.
Mar 14, 2026
Ultrasound-activated bubbles show promise for cancer therapy. Duke's SonoPIN killed 50% of cancer cells, while Case Western nanobubbles broke down tumor barriers, enabling potential trials in two years.
Jul 29, 2026
The Supreme Court allowed mifepristone to remain available via telehealth and mail while litigation continues. The FDA has also launched a six-month safety study of the abortion pill. Approximately 29% of U.S. abortions are now provided via telehealth.
May 27, 2026
The FDA replaced the two-trial approval requirement with a single pivotal trial standard, launched an AI pilot with AstraZeneca and Amgen, and extended the camizestrant review. A key FDA official is departing. AstraZeneca posted $58.74 billion in revenue.
May 27, 2026
The FDA extended the review deadline for AstraZeneca's camizestrant and issued a complete response letter for its COPD drug PT010. The agency also adopted a single-pivotal-trial approval policy, while AstraZeneca sold Losec rights to Cheplapharm.
Jul 01, 2026
The FDA approved Novocure's Optune Pax for locally advanced pancreatic cancer with gemcitabine and nab-paclitaxel, based on PANOVA-3 data showing improved overall survival. The device also earned a CE mark in Europe, with a planned launch in Germany.
Jul 13, 2026
The Supreme Court unanimously held in Hikma v. Amarin that induced infringement requires affirmative steps, not foreseeable or passive statements. The ruling raises the pleading bar for brand owners and extends beyond pharmaceutical skinny labels.
May 08, 2026
Market reports project growth in omics-based clinical trials, Asia digital PCR consumables, and multi-omic fluidic samplers. The clinical trials market is set to reach $47.78B by 2030; fluidic samplers grow to $2.76B by 2036.
Aug 04, 2026
Medidata launched Medidata Plus, an AI-native foundation that unifies AI capabilities across the clinical trial lifecycle. The platform accelerates study builds, enables no-code data transformation, and supports 80% of FDA novel drug approvals in 2025.
