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May 15, 2026
Phase 2 MINDFuL results for XPro1595 in early Alzheimer's disease were published, showing positive trends and no ARIA. FDA aligned on a phase 2b/3 registrational design. Webinar set for Feb 27, 2026.
Aug 08, 2026
TAVR panel at CRT 2026 explored the technology's current state and future. CathSAP's latest update includes new guidelines and trials, including EARLY TAVR and FDA approval for asymptomatic severe aortic stenosis.
Aug 04, 2026
FDA final guidance sets standards for psychedelic clinical trials. Federal agencies and states are advancing psilocybin and ibogaine research, and Eli Lilly is acquiring AtaiBeckley for $2.8 billion.
Jul 14, 2026
First-line pulsed field ablation achieved 56% vs 30% success with drugs in persistent AFib (HR 0.46). Device-related serious adverse events occurred in 5.1%. Results published in NEJM.
Aug 08, 2026
Recent studies have uncovered new cancer therapeutic targets and strategies, including self-assembling antibody-drug conjugates, a dual-action metabolic drug, and a BRAF protein structure. Research also advanced on dendritic cell vaccines, the origins of a rare childhood leukemia, and cancer cachexia treatment.
Apr 28, 2026
The Trump administration is reclassifying medical marijuana from Schedule I to Schedule III and accelerating psychedelic research with a $50 million executive order. The FDA commissioner says marijuana has medical benefits but warns of potency and risks to youth. The DEA says the rescheduling process remains pending.
Jul 15, 2026
Sponsors are adopting AI-enabled tools, integrated operating models and decentralized designs to accelerate clinical trials. FDA and EMA guidance underscores sponsor accountability, while new modeling links integrated operations to higher program value.
May 13, 2026
Aprea, Gain, and Grace Therapeutics posted quarterly updates featuring APR-1051 partial responses, an 81% average CSF GluSph reduction for GT-02287, and an April 23, 2026 PDUFA date for GTx-104.
Aug 07, 2026
Lyell Immunopharma initiated the Phase 3 PiNACLE–H2H trial of ronde-cel in large B-cell lymphoma and reported that GI prophylaxis reduced severe diarrhea rates from 55% to 10% in the Phase 1 LYL273 trial.
May 30, 2026
BioXcel completed a market assessment for at-home IGALMI use, finding strong prescriber and payer interest. The company submitted an sNDA for at-home use in acute agitation associated with bipolar disorders or schizophrenia.
Jul 31, 2026
FDA's advisory committee voted 9-0 that Moderna's mRNA flu vaccine mFlusiva benefits outweigh risks for adults 50-64 and 65+, clearing a key hurdle before an Aug. 5, 2026 decision. The FDA initially declined to review the BLA before reversing course.
Aug 06, 2026
Astellas Pharma reported fiscal 2026 sales of ¥2.14 trillion and net income of ¥291.54 billion, alongside an FDA Priority Review for PADCEV plus Keytruda in muscle-invasive bladder cancer. The company also settled U.S. Myrbetriq patent disputes with Lupin and Zydus. Shares trade at ¥2,470 with mixed valuation signals.
Jun 13, 2026
The FDA approved pivekimab sunirine-pvzy (Decnupaz) for adults with BPDCN on May 27, 2026, based on CADENZA trial data showing a 69.7% CR/CRc rate in treatment-naïve patients.
May 07, 2026
Madrigal expands MASH pipeline with siRNA licensing deals from Arrowhead and Ribo. Ribo deal includes $60M upfront and up to $4.4B milestones; IND submissions planned for 2026.
Jul 28, 2026
The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.
Aug 05, 2026
Xolair may be dropped from Medicare price negotiations as a biosimilar launch looms. The CMS must decide if the biosimilar is a true competitor. The outcome could set precedent for future biosimilar-facing selections.
Jun 20, 2026
Amgen shares have fallen 12.6% in three months despite relatively solid Q1 results, while Novo Nordisk maintains a 54.6% global GLP-1 market share. Both companies face pipeline competition and pricing pressures.
Jul 11, 2026
Takeda reported positive ENTYVIO pediatric data, secured FDA Priority Review for oveporexton, and expanded AI drug discovery. Shares trade at ¥5,609; analyst fair value is about ¥5,263.
Jul 10, 2026
Drug discovery success hinges on target, modality, and indication; over two-thirds of programs fail in Phase 2. Integrated strategies and disease-relevant models help reduce attrition. A Lonza webinar on April 22, 2026 covers CRISPR screening.
Aug 07, 2026
AI is transforming drug discovery across target ID, molecule design and trial optimization. Milestones include regulatory qualification of digital-twin controls and positive Phase 2a data, though 90-95% of candidates still fail.
