SS Innovations secures regulatory approvals for surgical robotic system in the Philippines, Ukraine
SS Innovations International (OTCPK:SSII) has received regulatory approvals for its SSi Mantra 3 Surgical Robotic System in both the Philippines and Ukraine, the company said on Friday. In addition to ...
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...
EurekAlert!16d
Re-purposed FDA-approved drug could help treat high-grade glioma
A study, published in Cancer Cell, shows that high-grade glioma tumor cells harboring DNA alterations in the gene PDGFRA responded to the drug avapritinib, which is already approved by the United ...
CNN18d
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
“Making these chemicals immediately illegal until obtaining FDA approval may cause disruptions in the food supply. Ensuring that existing GRAS chemicals are safe to remain in our foods should be ...
FiercePharma18d
Neurotech nabs FDA approval to treat rare eye disorder with cell therapy implant Encelto
The FDA last week approved (PDF) Neurotech’s cell therapy implant revakinagene taroretcel to treat the vision-robbing neurodegenerative disease macular telangiectasia (MacTel) type 2.
kffhealthnews19d
How the FDA Opens the Door to Risky Chemicals in America’s Food Supply
“That kind of casual neglect totally would be unacceptable in Europe,” Millstone said. ‘Several Decades Behind Europeans’ When the FDA formally approves substances for use in food, it can let decades ...
ophthalmologytimes19d
A new era for MacTel: Clinicians react to FDA approval of revakinagene taroretcel-lwey
The approval of revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals) as the first and only FDA-approved treatment for macular telangiectasia type 2 (MacTel) marks a significant milestone ...
Food Safety News21d
FDA increases import controls on some seafood and canned foods
The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...
Politico21d
FDA nominee pitches AI application review
“So that we don’t learn five years after Vioxx was approved that 38,000 Americans died from it,” he said. Open questions: But the Johns Hopkins surgeon also said the FDA could potentially ...
CBS News21d
How the FDA lets chemicals pour into America's food supply
When the FDA formally approves substances for use in food, it can let decades pass without reassessing them — even when subsequent research raises doubts about their safety. In the European ...
Cancer Therapy Advisor22d
Denosumab Biosimilars Stoboclo and Osenvelt Get FDA Approval
The products are expected to be available in June 2025. The US Food and Drug Administration (FDA) has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt ...