AbbVie Has Access In Mind With Myeloma Trispecific Antibody ABBV-2001
The drugmaker presented Phase I data for the CD38xBCMAxCD3-directed trispecific at the International Myeloma Society meeting in Glasgow, Scotland.
Scrip - September 26, 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

CHPA RSQ Conference: From AI To UV Filters, NAMs To Supply Chain Security
Presentations at Sept. 28-30 conference include leaders from FDA’s drug and medical device centers and supplement program outlining priorities and projects and workshop on new approach methods for drug studies.
HBW Insight - September 25, 2026

Lipo Flavonoid Fails To Support Earwax Removal Efficacy, Safety And Market Claims In NAD Review
NAD says Lipo fails to support express claims for Earwax Cleansing Kit & Aid Drops including “5 times faster than traditional cleansers” and “clinically tested formula” challenged by eosera.
HBW Insight - September 25, 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

The Trust Test: Why Health Leaders Should Rethink Who Speaks For Them
Jemilah Mahmood, exec director of Sunway Centre for Planetary Health, argues pharma companies should screen PR agencies for fossil fuel client ties, calling it "basic due diligence of credible climate and health leadership."
In Vivo - September 25, 2026

Should Pharma Care Who Else Its PR Agencies Work For?
A growing coalition of health organizations is calling on the pharmaceutical industry to stop working with PR companies that also serve fossil fuel clients, but an investigation found the question has not yet registered within pharma’s procurement practice.
In Vivo - September 25, 2026