Bayer’s positioning of Hyrnuo (sevabertinib) after accelerated approval for HER2-mutated nonsquamous NSCLC, especially diagnostic uptake and sequencing vs HER2 ADCs.

Selumetinib’s expanded use in adults with NF1 + symptomatic, inoperable plexiform neurofibromas, and whether adult adoption reshapes referral patterns.

AI-in-biotech momentum, with projections calling for a rise from $3.89B (2025) to $18.76B (2034), signaling growing investor focus on model-driven drug discovery.

FDA grants accelerated approval to Hyrnuo (sevabertinib) for HER2-mutated NSCLC

Approved for adults with locally advanced or metastatic nonsquamous NSCLC harboring HER2 tyrosine-kinase–domain activating mutations after prior systemic therapy. A targeted entry for a genomically tight lung cancer population. 👉 Read more

FDA expands selumetinib to adults with NF1 + inoperable plexiform neurofibromas

Previously available only for pediatrics, selumetinib now has an adult indication, broadening systemic treatment options in this rare tumor condition. 👉 Read more

Aflibercept 8 mg gains expanded dosing flexibility

Following the Aug 2025 high-dose approvals in wAMD/DME/DR and the Nov 2025 RVO extension, FDA added a monthly dosing option for select patients, enhancing clinic flexibility rather than creating a new approval. 👉 Read more

Sevabertinib adds a mutation-targeted HER2 option to a competitive lung cancer landscape, with resistance patterns and diagnostic penetration as key variables.

Selumetinib’s adult indication in NF1 + plexiform neurofibromas validates long-established MEK pathways beyond pediatric use.

ImPact Biotech will present updated Phase 3 ENLIGHTED padeliporfin VTP data in low-grade UTUC at SUO 2025.

Cell & gene therapy pipeline updates across oncology and rare diseases highlight steady early-stage progression amid selective funding.

Aflibercept 8 mg: Monthly dosing enhances optionality in VEGF-driven retina disease management.

AI-biotech market projected to grow from $3.89B (2025) to $18.76B (2034) at ~19% CAGR with strongest pull in discovery, omics analytics, and bioprocessing.

Regulation for AI drug discovery: Northeastern researchers propose frameworks focused on data provenance, model transparency, and lifecycle monitoring.

Antengene R&D Day highlighted progress in first-in-class oncology assets.

Overview: AI and model-driven R&D continued to show importance equal to molecule-driven innovation.

Dexcom received FDA clearance for basal insulin dosing software for adults with Type 2 diabetes.

Modular Medical submitted its Pivot tubeless insulin pump to FDA, targeting a 2026 launch.

Okami Medical raised $45M and appointed a new CEO to scale its embolization technologies.

Lumexa Imaging: IPO filing from Nov 17 aims to raise ~$200M, signaling investor appetite for imaging + surgical guidance platforms.

Duopharma Biotech posted 43.8% profit growth on 14% revenue growth through Q3.

States introducing oversight of private-equity healthcare ownership as consolidation accelerates.

Debate over ACA subsidy extensions continues, with proposals to channel funds toward HSAs instead.

Healthcare affordability framed increasingly as a math-driven issue as costs outpace wages.

HHS proposes expanded hepatitis B screening among maternal populations.

Approvals continue to cluster in targeted and rare conditions (HER2 NSCLC, NF1, retina).

AI biotech is transitioning from hype to infrastructure as forecasts gain credibility.

Medtech vertical integration and imaging-device convergence accelerated by AI collaborations.

U.S. biotech strategy vs China remains under scrutiny for cost and speed disadvantages.

Biotech & pharma stocks remain a relative safe haven despite broader market softness.

AI Biotech Market: $3.89B → $18.76B (2034)

Duopharma Profit: +43.8% YTD

XBI: ~114.5 (-0.6%)

IBB: ~165.2 (-0.7%)

Hyrnuo (sevabertinib) KOL reactions on sequencing and CDx usage.

Selumetinib adult NF1 adoption analysis from specialty centers.

Continued medtech AI + device commentary from MD&M + MEDevice Silicon Valley.