ASCO: Monjuvi Data Could Prompt Shift In Frontline DLBCL Treatment
Incyte presented results from the Phase III frontMIND trial of Monjuvi and lenalidomide added to R-CHOP, showing a significant increase in progression-free survival.
Scrip - May 30, 2026

Five Decades Of Device Oversight, From Ford’s Pen To Today
On May 28, 1976, President Ford signed the Medical Device Amendments into law, creating the risk-based framework that the FDA still relies on today. Fifty years later, CDRH marked the anniversary at its Maryland HQ. The timeline below traces the milestones that built modern device regulation.
Medtech Insight - May 29, 2026

Serious Injuries Linked To Second Recall Of Certain Insulet Omnipod Patches
Insulet is recalling millions of Omnipod pump patches due to a manufacturing issue that can result in patients not receiving adequate doses of insulin. The company reports 24 serious adverse events associated with the recall, which is the second recall of the devices this year.
Medtech Insight - May 29, 2026

Wrong Number: Court Nixes Bid To Pin Stanford’s LVAD Emergency Number Misstep On Abbott
Abbott Vascular recently came away with a victory in a California lawsuit concerning HeartMate 3 ventricular assist device, which was still an investigational device at the time of implant. However, at least one attorney believes that the concept of duty-to-innovate could feature in future cases.
Medtech Insight - May 29, 2026

FDA’s Latest Device Classifications Include TENS Unit, Condom, Anesthesia Tools
The US Food and Drug Administration has announced classifications for 11 device types that initially reached market via the de novo pathway, including diagnostics, the first condom specifically indicated for anal sex, and a TENS unit for pain management.
Medtech Insight - May 29, 2026

Execs On The Move: May 18–22, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - May 29, 2026

Diagnostics Manufacturers Are Falling Behind On Consumer Shift, Deloitte Warns
New research exposes a series of strategic disconnects between what providers need and what manufacturers deliver, just as patient-initiated testing threatens to reshape the market.
Medtech Insight - May 29, 2026

Elixir Medical’s DynamX Lowers Cardiovascular Death By 88% vs. Medtronic’s DES, Data Show
Four-year data showed Elixir Medical’s DynamX bioadaptor had a 66% lower target lesion failure rate and an 88% reduction in cardiovascular death versus Medtronic’s Resolute Onyx drug-eluting stent (DES).
Medtech Insight - May 29, 2026

K-Beauty Ingredients PDRN, Volufiline Lighting Up US TikTok Shop – Report
TikTok Shop videos featuring anti-aging ingredient PDRN and patented skin plumping extract Volufiline are generating hundreds of millions of hits, according to a report by ecommerce brand discovery and analysis platform company Charm.io.
HBW Insight - May 30, 2026

Biogen Faces Italian Investigation Over Blocking Sandoz’s Biosimilar Natalizumab
Biogen is being investigated by Italy’s AGCM competition authority over concerns that the company may have pursued a strategy designed to exclude and limit competition from Sandoz’s Tyruko (natalizumab) biosimilar rival to the originator’s Tysabri.
Generics Bulletin - May 29, 2026

Medicines Patent Pool Targets Xofluza Access Through New Roche Licensing Agreement
The Medicines Patent Pool has entered into a new licensing agreement with Roche for Xofluza, an innovative antiviral for influenza treatment. This agreement was announced alongside the launch of the MPP’s new five–year strategy, also aimed at improving global medicines access.
Generics Bulletin - May 29, 2026

Outlook Sees The Finish Line As It Wins Appeal Against FDA
A favorable appeal ruling gives Outlook Therapeutics its clearest US regulatory signal yet, but with $7.7m in cash and European sales sliding, the timing has never mattered more.
Generics Bulletin - May 29, 2026

Apotex Opens Its Books As It Unveils IPO Plans
Apotex has announced plans to go public, filing a preliminary prospectus for an initial public offering that reveals detailed financial data, as it set out its ambition to “evolve from a leading generics manufacturer into a diversified, Canadian-based global health company.”
Generics Bulletin - May 29, 2026

Podcast: Decoding Cell Stress At Soley Therapeutics
In this episode of the In Vivo podcast, Soley Therapeutics CEO and UCSF cardiologist Yerem Yeghiazarians explains how decoding cell stress with live?cell imaging and artificial intelligence is powering a first?in?class oncology pipeline and beyond.
In Vivo - May 29, 2026