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TELA Bio Launched Hernia Mesh Fixation Devices; Stryker Acquisition of SERF SAS; FDA 510(k) Clearance for RedDrop Dx’s Blood Collection Device; FDA 510(k) Clearance for Next Generation Shaw Scalpel; LivaNova’s Sleep Apnoea Device Trial; Nanodropper’s Positive Impact on Glaucoma Treatment
TELA Bio Launched FDA-approved Hernia Mesh Fixation Devices On March 21, 2024, TELA Bio, Inc., a medical technology firm, launched its FDA-approved LIQUIFIX devices for hernia repairs in the United States. The LIQUIFIX FIX8™ and LIQUIFIX Precision™ are specifically engineered for laparoscopic and open femoral and inguinal hernia repairs, respectively. These devices are the sole FDA-approved choices for securing mesh and bringing peritoneal tissue into proximity using liquid anchors. This method has the potential to diminish mechanical tissue damage by eliminating the need for penetrating tacks, sutures, or staples. By…
Botanical Bounty: Cracking the Herbal Medicine Market Enigma and Growth Potential
Herbal Medicine, rooted in ancient traditions across cultures worldwide, has witnessed a remarkable evolution in the modern era. The global Herbal Medicine Market has experienced significant growth over the years, fueled by a resurgence of interest in natural remedies and a growing awareness of the potential health benefits offered by botanical extracts. From traditional herbal preparations to standardized extracts and modern formulations, the market has expanded to cater to diverse consumer needs and preferences. Herbal Medicine offers a plethora of benefits, including holistic approaches to health, reduced side effects compared…
Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition
Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), each occurring after two or more lines of systemic therapy. The sole concern for approval is associated with the status of enrollment in the confirmatory trials. The CRLs, one for R/R FL and one for R/R DLBCL did not highlight any concerns regarding…