Double Billing: Regeneron MFN Deal Announced Along With Approval Of Its Gene Therapy
Treatment for deafness is the first gene therapy approved under the FDA Commissioner’s National Priority Voucher program.
Scrip - April 24, 2026

MedCon Day 2: FDA Officials Update Stakeholders On New Risk-Based Inspection Regime
FDA officials offered stakeholders at MedCon a look at the updated compliance program for medical device inspection under the new QMSR, which went into effect in February. The new program centers around risk management. Class I recalls also increased in 2025.
Medtech Insight - April 23, 2026

CMS And FDA Propose RAPID Path For Faster Reimbursement
FDA and CMS proposed a new pathway, RAPID, to close the gap between device approval and Medicare coverage by aligning review and coverage decisions upfront. The pathway will be open to Class III, breakthrough, and TAP Class II devices that meet certain standards.
Medtech Insight - April 23, 2026

AcuityMD Raises $80M To Bring Agentic AI To Medtech Sales
AcuityMD, whose medtech sales software serves more than 400 medtech companies, has closed an $80 million Series C round led by StepStone Group. It plans to use the proceeds to accelerate development of agentic AI capabilities and strengthen its data model.
Medtech Insight - April 23, 2026

Boston Scientific Adjusts To New PFA Landscape As Medtronic, J&J And Abbott Take Market Share
Boston Scientific beat Q1 expectations – then cut its full-year guidance by more than three percentage points. The reason is sitting in three competitors' cath labs: Medtronic, J&J and Abbott are taking PFA share faster than Boston Scientific anticipated, and the company is now saying so directly.
Medtech Insight - April 23, 2026

Execs On The Move: April 13–17, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - April 23, 2026

IMDRF AI Framework Could Alter Cost Of Compliance
A new IMDRF draft framework suggests manufacturers of AI-enabled medical devices should implement continuous monitoring, data transparency and performance management through the entire lifecycle of the product.
Medtech Insight - April 23, 2026

EU’s PFAS In Supplement Packaging Rules Coming Into Force Soon
Dietary supplement packaging for products sold in the EU must not exceed new limits on per? and polyfluoroalkyl substances set to be introduced from August this year.
HBW Insight - April 23, 2026

Reckitt Weighed Down By Sluggish Cold & Flu Season
Lower incidence of cold & flu in North America and Europe held back Reckitt's Self-Care category performance in Q1. Bright spots for the business included stronger demand for dietary supplements and heartburn brand Gaviscon.
HBW Insight - April 23, 2026

Amneal Joins The Biosimilar A-List With $1bn+ Kashiv Buyout
With a deal worth more than a billion dollars to buy Kashiv BioSciences, Amneal has made it clear that it intends to compete at the highest level in biosimilars. The firm’s leaders set out strategic plans for the future, the value of vertical integration and how Amneal views its closest competitors.
Generics Bulletin - April 23, 2026

Cipla Breaks Ventolin Barrier In US Generics
Cipla has won FDA approval for the first AB-rated generic Ventolin HFA, opening up automatic substitution in a $1.5bn US albuterol inhaler market and expanding its respiratory franchise with planned manufacturing from a new Massachusetts inhalation facility.
Generics Bulletin - April 23, 2026

Prestige Biopharma Targets Easier Biosimilar Injections
Prestige Biopharma has patented a gel-forming subcutaneous delivery platform aimed at creating a differentiated version of its trastuzumab biosimilar, potentially improving convenience, dosing and competitiveness in Europe’s crowded oncology biosimilar market.
Generics Bulletin - April 23, 2026

Partial Inhibition, Full Ambition: Regeneron Bets Its Neurology Future On Cemdisiran
With an FDA submission confirmed and a priority review voucher in play, Regeneron is targeting a year-end approval, but the competitive math in gMG is unforgiving.
In Vivo - April 22, 2026

Pharma’s Pipeline Size Dipped In 2025
There has been a fall in the number of drugs in development, latest annual data from Citeline show, but the figure is thought to point to a flattening, rather than contracting, of the pipeline.
In Vivo - April 22, 2026

The 10-80-10 Investment Rule: Preparation Is All
It's never an even playing field for healthtech founders seeking investor interest. A high-level BioWales 2026 panel offered advice to hopeful entrepreneurs.
In Vivo - April 22, 2026