Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: China’s transforming effect; Novo’s new strategy; Roche’s obesity contender; Amgen’s Sjögren’s win; and potential Chinese blockbusters.
Scrip - September 28, 2026

New FDA Guidance Opens A Common Playbook For Surgical Robot Makers
The FDA's first dedicated guidance for robotically assisted surgical devices details submission requirements across 510(k), PMA, and De Novo pathways and introduces an umbrella framework allowing data from complex procedures to support authorization of related ones.
Medtech Insight - September 25, 2026

FDA Nominee Overton Pledges Science-Driven Approach, Defends Trump Vaccine Rhetoric
FDA Commissioner-nominee Heidi Overton walked the line between backing the Trump administration and prioritizing science during her Sept. 24 Senate confirmation hearing.
Medtech Insight - September 25, 2026

Another Safety Alert For Impella As Abiomed Warns Of Controller Failure
FDA alert is 14th in three years as Impella faces growing questions about its safety and efficacy.
Medtech Insight - September 25, 2026

GLP-1 Giant Eli Lilly Eyes $100m Oura Stake As Smart-Ring Maker Heads For IPO
Oura is asking public markets to value a sleep-tracking ring at $16bn, with Eli Lilly and Dragoneer lined up as early buyers — a filing that arrives on the back of $1.21bn in nine-month revenue and 74% year-on-year growth.
Medtech Insight - September 25, 2026

Three Topics Dominated US FDA Commissioner Nominee Overton’s Senate Hearing
Heidi Overton's FDA confirmation hearing was less about running the agency and more about navigating three political minefields: mifepristone, vaccines and flavored vapes.
HBW Insight - September 28, 2026

BsUFA IV Agreement Includes Push To Reduce Revenue, Cuts Product Development Fees
The changes should lead to lower annual revenue targets and will eliminate fees created in 2012 to help the program’s growth.
Generics Bulletin - September 25, 2026

NRx Speeds Up Ketamine Verdict With FDA Revision
NRx Pharmaceuticals has reported positive news on its ANDA for preservative-free IV ketamine, with the FDA moving up the product’s GDUFA goal date to Nov. 10 after reclassifying an ANDA amendment from major to minor.
Generics Bulletin - September 25, 2026

MPP Targets Pandemic Preparedness With Xofluza Generic Licenses
The Medicines Patent Pool has granted 11 sub-licensees the right to develop, manufacture and supply generic versions of Roche’s Xofluza (baloxavir marboxil) in 129 low- and middle-income countries.
Generics Bulletin - September 25, 2026

Is The UK Becoming A Cautionary Tale For Off-Patent Markets?
The UK off-patent sector is showing the strain of a decade of price compression, with over 60% of generic volume now reimbursed at under £1 for a month's supply. Medicines UK chair Paul Burden argues the market has passed the point of sustainability.
In Vivo - September 28, 2026

AI-Powered CT Imaging: New Opportunities For Non-Invasive CAD Diagnosis
Global diagnostic imaging major Royal Philips is using partnership approaches to achieve clinical validation of its computed tomography-based integrated care pathway for patients with coronary artery disease.
In Vivo - September 28, 2026