FDA Probes Elevidys Deaths, Stirring Regulatory and Market Uncertainty
FDA investigates Elevidys deaths, raising new safety and regulatory questions for gene therapies.
Month: June 2025
Gilead Taps Kymera in $750M Oncology Deal to Harness Molecular Glue Degraders
Gilead and Kymera seal a $750M deal for innovative CDK2 molecular glue degraders in oncology.
Neuron23’s NEU-411 Trial Shifts the Parkinson’s Paradigm Toward Precision
Neuron23 advances NEU-411 into Phase II Parkinson’s trial, driven by biomarker-based strategies and strong investor support.
NICE Expands TAVI Guidance for Aortic Valve Regurgitation
Quick Summary: NICE has published new interventional procedures guidance recommending the use of transcatheter aortic valve implantation (TAVI) for patients with native aortic valve regurgitation. This guidance enables wider access to TAVI as a less invasive alternative to open-heart surgery for eligible NHS patients, with a key focus on multidisciplinary team-based patient selection and … Read more
NICE Guidance Catalyzes Digital Mental Health Innovation
NICE empowers NHS with digital health tech for children’s mental health, boosting access and efficiency.
Benlysta Autoinjector Approval Transforming Pediatric Lupus Nephritis Management
GSK’s Benlysta autoinjector gains FDA nod for pediatric lupus nephritis, enabling at-home treatment.
SINTX Enters the $1.3B Foot and Ankle Implants Market with SiNAPTIC Acquisition
SINTX acquires SiNAPTIC assets, targeting the $1.3B foot and ankle fusion implant market.
Digital Pathology Clearance Accelerates U.S. Market Entry
PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.
TISSIUM’s De Novo FDA Authorization Signals Industry Shift
FDA De Novo nod for TISSIUM’s COAPTIUM CONNECT: a new era in sutureless nerve repair.
Revolution Medicines Secures Powerhouse $2B Funding in Groundbreaking Royalty Pharma Deal
Revolution inks $2B flexible deal with Royalty Pharma to fund RAS(ON) inhibitors in cancer.