ESMO 2026: Sac-TMT Blazes Trail For Chemo-Free ADC/IO Regimen In 1L NSCLC
In a global-first for antibody-drug conjugates, Kelun-Biotech/Merck’s sacituzumab tirumotecan is set to supersede chemotherapy in combination with Keytruda in first-line, PD-L1-negative non-squamous non-small cell lung cancer, based on strong progression-free survival outcomes.
Scrip - October 26, 2026

Scrip’s Five Must-Know Things: Key ESMO Readouts, Next-Gen ADCs And Mid-Cap Winners
In this week's episode: key expectations from ESMO meeting; next-generation antibody-drug conjugates; rising mid-cap stars; GSK's novel hepatitis B launch; and significant private company financings.
Scrip - October 26, 2026

Most AI Scribe Companies Don’t Realize They’re Making Medical Devices, Says TGA
Australia’s regulator weighs in on debate about whether intention or function should decide regulatory status for AI products.  
Medtech Insight - October 25, 2026

US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office
FDA retired Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead new Office of Mission Information Technology Services as agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
HBW Insight - October 26, 2026

Zydus Receives FDA Approval For First Generic Climara Pro
The US regulator has approved Zydus’s once-weekly transdermal hormone therapy patch for estradiol and levonorgestrel as a competitive generic therapy, triggering eligibility for a 180-day exclusivity period.
Generics Bulletin - October 23, 2026

France’s Alma Urges Off-Patent Exemption From Latest Legislative Burdens
French off-patent industry association Alma has urged revisions to the country’s latest social security financing bill to avoid penalizing generics and biosimilars.
Generics Bulletin - October 23, 2026

Formycon Goes After Its First Niche-Buster Biosimilar With A Latin American Partner
Formycon has partnered with Uruguay-based Biocelys to develop an undisclosed “niche-buster” biosimilar, FYB286, targeting a rare disease. The deal is financed upfront by Santo Biosimilar, an entity controlled by Athos KG, which also controls Biocelys and is Formycon’s largest anchor shareholder.
Generics Bulletin - October 23, 2026

The Biological Case for Adopting New Approach Methodologies in Oncology
The FDA’s oncology draft guidance supports using human-relevant NAMs to replace or augment animal toxicology studies, with biologics and ADCs best positioned because their targeted behavior makes safety predictable.
In Vivo - October 23, 2026