Shionogi Eyes Growth From Radicava, Torii Business This Fiscal Year
Japanese firm eyes 40% revenue growth this fiscal year, boosted by acquisitions of Torii and Radicava, despite a big slowdown for its oral COVID-19 antiviral.
Scrip - May 14, 2026

HistoSonics’ FDA Kidney Filing Would Push Focused Ultrasound Tumor Treatment Beyond The Liver
Minneapolis-based HistoSonics has filed a de novo application with the US FDA on the use of its Edison Histotripsy System to treat kidney tumors. If granted, it would be the Edison’s first cleared indication outside the liver.
Medtech Insight - May 13, 2026

Deals Shaping The Medtech And Diagnostics Industries, April 2026
An interactive look at medtech and diagnostics deals made during April 2026. Data courtesy of Biomedtracker.
Medtech Insight - May 13, 2026

No Inspection Date, No Warning Letter Clarity: Olympus Carries FDA Uncertainty Into FY2027
Olympus closed FY2026 with $6.4bn in revenue and plans to cut 2,000 jobs – but the harder story is what remains unresolved: no FDA reinspection date for Aizu, no warning letter clarity and products still on ship-hold stretching into the second half of FY2027.
Medtech Insight - May 13, 2026

Roche Aims To Differentiate With AI, High-Burden Diseases
At its 2026 Diagnostics Day, Roche discussed plans for PathAI and differentiation through early testing in oncology, neurology, infectious diseases and cardiometabolic diseases.
Medtech Insight - May 13, 2026

FDA Offers Clarity On New Adverse Event Monitoring System For eMDR Submitters
The US FDA issued an update Tuesday on how its recently consolidated Adverse Event Monitoring System affects stakeholders submitting electronic medical device reports. The new AEMS, which the agency rolled out in March, replaced the decades-old MAUDE.
Medtech Insight - May 13, 2026

Motif Neurotech Begins Its Biggest Test Yet, And So Does Therapeutic BCI
Motif Neurotech's FDA-authorized trial for a minimally invasive brain implant marks a milestone for therapeutic BCI, but the field still faces fundamental questions about how to read, measure and respond to the brain's role in mental illness.
Medtech Insight - May 13, 2026

Exero Medical Seeks FDA Clearance For xBar Leak-Detection System After Pivotal Trial Success
A pivotal 222-patient study shows Exero Medical's xBar system can detect colorectal anastomotic leaks more than three days earlier than standard care. The company is now seeking FDA clearance, with potential US launch in 2027.
Medtech Insight - May 13, 2026

Makary Leaves OTC Mark As FDA Commissioner But One Consumer Health Blank Space Resonates
Martin Makary established himself after becoming commissioner in March 2025 as an ally for OTC drug providers by saying on multiple occasions that more drugs should be available nonprescription.
HBW Insight - May 14, 2026

Dr Reddy’s Sets Out Details Of Imminent Semaglutide Launch In Canada
During Dr Reddy’s full-year results call, management set out expectations for the firm’s imminent launch in Canada of the country’s first generic semaglutide rival to Ozempic – while also providing updates on the Indian firm’s biosimilars business.
Generics Bulletin - May 13, 2026

Regulatory Recap: UK’s Dormant License Rival Project To Close Applications In June
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - May 13, 2026

Viatris Targets US GLP-1s With Auto-Injector Strategy
Viatris has ambitions to become “a significant player” in GLP-1s, identifying the US as a key focus as it looks to differentiate itself from other prospective generic competitors through device expertise and the development of “the right auto-injector” to support substitutability.
Generics Bulletin - May 13, 2026

Jamjoom Adds Scale As Saudi Localization Momentum Builds
Jamjoom Pharma has announced separate agreements involving Viatris and Pfizer, moving closer toward its Saudi localization strategy and adding impetus behind its broader generics, biosimilars and biologics ambitions.
Generics Bulletin - May 13, 2026

Off-Patent Industry Loses A Champion As Makary Leaves US FDA
Marty Makary’s departure as FDA commissioner means the off-patent industry will lose a figure who has championed its cause in the past year, particularly on biosimilar streamlining and interchangeability.
Generics Bulletin - May 13, 2026

Gifrer Acquisition To Boost Celltrion’s French Reach, Portfolio
Celltrion acquiring Gifrer to strengthen its commercial footprint in France, better respond to the French government's biosimilar substitution policy and diversify its product portfolio beyond prescription biologics.
Generics Bulletin - May 13, 2026

Amgen’s Pavblu Drives?Growth While Prolia/Xgeva Erosion Begins?
Amgen’s quarterly earnings report highlighted both the successes and challenges facing its portfolio.
Generics Bulletin - May 13, 2026

Deals Shaping The Industry, April 2026
An interactive look at pharma, medtech and diagnostics deals made during April 2026. Data courtesy of Biomedtracker.
In Vivo - May 13, 2026

Precision’s Proving Ground: The Drug Classes Reshaping Blood Cancer Treatment
In this article, the third of the oncology therapeutic review series, In Vivo looks at hematologic malignancies.
In Vivo - May 13, 2026