By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a way that, while positioned as a public health measure, also grants investors greater visibility into regulatory decisions. Experts question whether this is the agency’s proper remit.
Wall Street the Main Beneficiary of FDA’s Real-Time CRL Disclosures Read More »
The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and granted approvals in Barth syndrome and for a subcutaneous version of Merck’s Keytruda that could be key to the blockbuster’s future earnings.
September’s FDA Action Bolsters Keytruda, Ultra-Rare Disease but Deals Two SMA Defeats Read More »
Naveen Kumar Amar joins the surgical robot developer as it prepares to expand globally, including in Europe and the U.S.
The device, called Biolinq Shine, is indicated for people with Type 2 diabetes who don’t depend on insulin.
Biolinq gets FDA de novo nod for intradermal glucose sensor Read More »
On Thursday, Texas Judge Reed O’Connor threw out a Biden-era rule that would have recouped billions of dollars in overpayments to MA plans.
Judge vacates Medicare Advantage audit rule in win for industry Read More »
The request includes a call to postpone re-certification requirements for devices already certified under the medical technology regulations.
MedTech Europe pressures EU to make regulatory changes by early 2026 Read More »
El entorno empresarial moderno está siendo transformado por la rápida adopción de tecnologías emergentes. Herramientas como la inteligencia artificial, blockchain, el internet de las cosas, la realidad aumentada y virtual, y la automatización robótica de pro …
Tecnologías que están marcando el nuevo rumbo empresarial Read More »
The company was awaiting $70 million from HealthCare Royalty but missed an agreed-upon payment condition.
Heidelberg Pharma Misses Out on Royalty Payment, Plans 75% Workforce Cut Read More »
The Trump administration has used the investigations in other sectors to implement tariffs, but the earliest any potential actions would take place is summer 2026, analysts said.
Section 232 probe reignites tariff uncertainty for medtech firms Read More »
It’s the latest warning about the impact to the healthcare system if the subsidies are allowed to lapse, an issue at the center of the government funding fight taking place on Capitol Hill.
Hospitals, doctors could lose $32B in revenue next year if ACA subsidies expire: report Read More »
