Korea Q1 Roundup: Hanmi Gears For Obesity Launch, Strong Growth For SK Biopharm
Major South Korean pharma firms’ mostly solid first-quarter earnings, helped by overseas sales of in-house prescription drugs.
Scrip - May 11, 2026

Curacle Inks $1bn Bispecific Deal With Memento
Curacle and MabTics out-license MT-103, a bispecific antibody targeting retinal diseases, to US-based Memento Medicines in a deal potentially worth just over $1bn.
Scrip - May 11, 2026

Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: Novo winning early oral obesity market; GSK deal bolsters downstream obesity strategy; brighter Pfizer outlook due to Vyndamax settlements; China dominates record novel drug launches; and J&J drops two lymphoma CAR-Ts.
Scrip - May 11, 2026

More Resources, More Harm: Medical Device Cyberattacks Worsen Despite Defenses
New survey data exposes a deepening paradox: healthcare organizations are taking security more seriously than ever, yet cyberattacks on medical devices are becoming more frequent and more damaging to patient care.
Medtech Insight - May 8, 2026

White House’s Revealing Response To Reports Of Makary’s Imminent Ouster
A White House spokesperson provided Medtech Insight with a vague response to multiple reports suggesting Marty Makary’s tenure as US FDA commissioner is coming to an end, while a current reviewer at the agency said Makary’s ouster would be a “disaster.”
Medtech Insight - May 8, 2026

Global Medtech Guidance Tracker: April 2026
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.
Medtech Insight - May 8, 2026

FDA Continues AI Expansion, Launches Updated Elsa Platform
The US FDA has completed the consolidation of its data platform and launched Elsa 4.0, a “significant” upgrade to the AI tool that was installed across the agency last year to streamline workflows and help investigators and reviewers expedite their work.
Medtech Insight - May 8, 2026

Fractyl Health’s CEO On How Revita Plans To Solve The Post-GLP-1 Weight-Regain Puzzle
With more than half of GLP-1 users quitting within a year — and weight rebounding fast —Fractyl Health is betting on a one?time duodenal procedure to lock in metabolic gains. Pivotal data are due in early Q4 2026.
Medtech Insight - May 8, 2026

Regulatory Uncertainty Slows EU AI Innovation, Data Suggests
EU has significantly lower AI medical device approvals and clinical trials than the US, study finds.
Medtech Insight - May 8, 2026

Siemens Healthineers Kicks Off Diagnostics Carve-Out, Cuts Full-Year Revenue Outlook
Siemens Healthineers has launched a formal process to separate its Diagnostics business and lowered its full-year revenue growth guidance to 4.5–5%, as structural market changes in China pushed down the division's quarterly margin.
Medtech Insight - May 8, 2026

Alcon Bets On New Launches To Offset Cataract Market Challenge
Alcon's Q1 revenue missed estimates as cataract softness and rising competition weighed on implantables. New launches are partially offsetting the pressure, but J&J MedTech's FDA-approved premium IOL entry sharpens the competitive test ahead.
Medtech Insight - May 8, 2026

US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency
One-day inspections could help broaden the FDA's domestic and foreign surveillance reach and would employ artificial intelligence to identify low-risk facilities.
HBW Insight - May 11, 2026

Growing GRAS Change From Idea To Proposed Rule Takes Time – FDA Foods Program Chief
“Any reports that the administration doesn't support” HHS Secretary Kennedy’s proposal to cut the GRAS self-affirmation option, “I would say are not accurate,” says FDA Human Foods Program director Kyle Diamantas.
HBW Insight - May 11, 2026

‘Dietary Substance For Use To Supplement The Diet’? US FDA Plans To Answer With Guidance
“Getting some clarity so we all know what we're looking at when we think about a dietary substance for use by man to supplement the diet by increasing the total dietary intake. It's clear as mud,” says FDA supplement programs director Cara Welch.
HBW Insight - May 11, 2026

BsUFA IV Talks Begin With Supplement, Fee System Streamlining Proposals
US FDA and the biosimilars industry want to reduce supplement categories, including some review times, as well as eliminate some fees during the next program cycle.
Generics Bulletin - May 8, 2026

Aurobindo’s CuraTeQ Secures Canadian Bevacizumab Approval
Looking to continue expansion of its biosimilars portfolio, Aurobindo has secured Health Canada approval for its Bevqolva version of bevacizumab that is set to challenge Avastin – along with several other rivals already in the market.
Generics Bulletin - May 8, 2026

Who’s Hired? Viatris Begins Search For New CFO
Viatris is looking for a new chief financial officer after the current CFO announced plans to step down. Meanwhile, Alvotech and Sandoz are also waving goodbye to high-level executives at the same time as CNX, Par, Fresenius Kabi and Teva announce appointments.
Generics Bulletin - May 8, 2026

Synthon Invests In R&D Expansion
Synthon has announced an investment in expanding its R&D capabilities to support API development.
Generics Bulletin - May 8, 2026

Getting Medtech Right In A Small Country
Gwyn Tudor, head of the MediWales forum, lays out the challenges, opportunities and funding on offer for healthtech founders who make Wales part of their strategic plan.
In Vivo - May 8, 2026

How The Tailwind Of AI Is Taking Cardiovascular Healthtech Convergence To New Levels
Israel-based global healthtech innovation expert Gilad Glick previews a Biomed Israel 2026 session on how convergence of health technologies and AI-driven risk prediction are transforming cardiovascular medicine.
In Vivo - May 8, 2026