All Blogs

Aug 28, 2024

Vaccinia virus-associated oncolytic virus therapies represent a promising approach to cancer treatment, leveraging the ability of the vaccinia virus to selectively infect and destroy cancer cells. The vaccinia virus, historically used in the smallpox vaccine, has been engineered to serve as an oncolytic virus due t...

Aug 27, 2024

Merck’s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR™ (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU me...

Aug 26, 2024

The BCG vaccine, a significant medical breakthrough developed in the early 20th century, is derived from a strain of Mycobacterium bovis initially created by the University of Illinois as a vaccine against tuberculosis. For NMIBC, BCG is administered intravesically to reduce the risk of cancer recurrence and progre...

Mar 25, 2026

Summary In 2023, the total diagnosed prevalent cases of hypophosphatasia, an ultra-rare disease, were approximately 6,200 in the 7MM. While almost 85% have less severe forms of the disease, severity may vary based on genetic and environmental factors. Due to the low number of diagnosed cases, few companies h...

Aug 22, 2024

Guard Medical Announced FDA 510(k) Clearance for Additional Large Sizes of its NPseal ® Surgical Dressing, Marking Product's Entry into the Orthopedic Market On August 19, 2024, Guard Medical, Inc., a medical technology company, announced FDA 510(k) clearance for expanded large sizes (up to 25cm) of its advanced...

Mar 12, 2025

Obesity is the second leading cause of preventable death and is linked to numerous inflammatory conditions, which contribute to diseases like cardiovascular disease, diabetes, respiratory issues, mental health disorders, hypertension, obstructive sleep apnea, cancer, and high cholesterol. This poses a significant p...

Aug 20, 2024

Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (...

Aug 19, 2024

The first horse bearing Novartis’ IgAN treatment has reached the FDA’s approval milestone. FABHALTA is approved for use in treating IgAN patients who are at risk of swift disease progression, as evidenced by a urine protein-to-creatinine ratio of 1.5 g/g or higher. On August 8, the FDA approved the use of Novart...

Aug 15, 2024

The Masimo W1® Medical Watch Secured FDA 510(K) Clearance for its Connectivity with the Masimo Safetynet® Telemonitoring System  On August 12, 2024, Masimo announced that its Masimo W1® medical watch received FDA 510(k) clearance for connectivity. This approval enabled the watch to integrate with the Masimo...

Aug 16, 2024

A year after rejecting it, the FDA has now approved Ascendis Pharma’s once-daily injectable YORVIPATH for hypoparathyroidism treatment. Ascendis Pharma’s YORVIPATH (palopegteriparatide), formerly called TransCon PTH, has been approved for the treatment of adults with hypoparathyroidism. This rare condition, charact...