Regulatory

NX Taiwan Secures TFDA Certification for Medical Device Quality Management—A First for a Japanese Company

Nippon Express (Taiwan) Co., Ltd. earns medical device QMS certification for its NEXT3 warehouse in Taoyuan, reinforcing its capabilities in compliant storage, packaging, and labeling of medical devices to meet Taiwan’s stringent quality control standards. ...

Sanofi’s Merilog Wins FDA Approval as First Rapid-Acting Insulin Biosimilar for Diabetes

The U.S. FDA has approved Merilog (insulin-aspart-szjj), Sanofi’s biosimilar to Novolog, marking a significant step toward expanding access to affordable insulin. The approval strengthens competition in the diabetes treatment market, offering a new rapid-acting insulin option for millions of patients. ...

Navi Medical Secures FDA Clearance for Neonav® Pediatric Vascular Access System

The first-of-its-kind system, designed specifically for neonatal and pediatric patients, leverages real-time ECG signal analysis to improve CVAD placement, enhance patient safety, and reduce complications, marking a major milestone in global pediatric healthcare....

Evolus Secures FDA Approval for Evolysse™ Hyaluronic Acid Gels

New Evolysse™ Form and Smooth injectables enhance aesthetic treatment options....

PHC and CCRM Partner to Optimize T-Cell Expansion for Advanced Cell Therapies

Collaboration aims to enhance efficiency and improve cell quality in primary T-cell culture processes....

Wyss Center Partners with BrainScape Medical to License Groundbreaking Epios® Technology

The collaboration aims to drive long-term brain monitoring and neurostimulation innovations into clinical applications....

BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value

Compelling opportunity expected to unlock substantial value through enhanced focus, tailored investment and capital allocation, and optimized market valuation ...

Womens Wellness brand NUA Raises Rs 35 Crore in Pre-Series C led by Mirabilis Investment Trust

● Round also saw participation from notable investors including Samir Singh, EVP - Asia, Colgate Palmolive & Former Chair of Unilever SE Asia, Shuchi Kothari, Head of DSP Family Office and SRF Limited ● Company turned profitable in Q2 FY24-25 and crossed Rs. 100 Cr net revenue ARR in Q3 ● Company aims to clock Rs. 150 Cr net revenue ARR in the next quarter. ● Funds raised will be deployed for retail expansion and new product introduction across key channels ...

EyeYon Medical expands operations with New Subsidiary in China

The move aims to strengthen EyeYon’s presence in Asia and enhance access to its innovative ophthalmic solutions....

FDA approves Roche’s Susvimo as first continuous delivery treatment for Diabetes-Related Blindness

Susvimo becomes the only FDA-approved therapy offering continuous drug delivery for diabetic eye disease....