FDA

Baxter Introduced New Injectable Pharmaceuticals to US Market On April 11, 2024, the pharmaceutical portfolio of multinational medical goods corporation Baxter International Inc. was augmented with the introduction of five new injectable medications in the US market. The goods were made to fulfill essential dema...

Roche's Columvi Achieves Primary Endpoint of Prolonged Overall Survival in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Trial Roche reported that the Phase III STARGLO trial successfully achieved its main goal of improving overall survival. The research revealed that in...

Carl Zeiss Meditec AG Completed Acquisition of Dutch Ophthalmic Research Center (D.O.R.C); Companies Unite to Shape Ophthalmology Market  On April 04, 2024, Carl Zeiss Meditec AG announced that it acquired D.O.R.C. (Dutch Ophthalmic Research Center) from the investment firm Eurazeo SE, Paris, France. T...

Enhertu Receives US Approval as First HER2-focused Treatment for Metastatic Solid Tumors, Independent of Tumor Origin AstraZeneca and Daiichi Sankyo's drug Enhertu (trastuzumab deruxtecan) has gained approval in the United States for treating adult patients with inoperable or metastatic HER2-positive (IHC 3+) so...

C2Dx Launched Next Generation Shaw Scalpel System  On March 26, 2024, C2Dx, a privately-owned medical device company, announced the launch of its Next Generation Shaw Scalpel System. The Shaw Scalpel System has obtained 510(k) clearance from the FDA for the upgraded controller of its advanced surgical techn...

Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH Voydeya (danicopan) has received approval in the United States for use alongside ravulizumab or eculizumab in treating extravascular hemolysis (EVH) in adults dia...

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 femo...

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...

Vygon Launched Neonatal Safety in India with Groundbreaking Nutrisafe2 System  On March 15, 2024, Vygon, a leader in the production and marketing of specialized medical equipment, introduced Nutrisafe2, a technological leap forward. This state-of-the-art enteral feeding device for neonates guarantees the sa...

MangoRx Officially Launches ‘PRIME’ by MangoRx, Powered by Kyzatrex®️ FDA Approved Oral Testosterone Replacement Therapy (TRT) Treatment On March 12, 2024, Mangoceuticals, Inc. unveiled a groundbreaking development eagerly awaited by many: the launch of 'PRIME' by MangoRx, Powered by Kyzatrex®️. This release mar...