Tag: US FDA

FDA authorizes Virtual Incision’s MIRA: A leap forward in robotic-assisted surgery

businessnewstoday- February 25, 2024

Virtual Incision Corporation has achieved a groundbreaking milestone with the U.S. Food and Drug Administration (FDA) granting marketing authorization for the MIRA Surgical System (MIRA), ... Read More

FDA approves biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals

businessnewstoday- February 25, 2024

Alvotech and Teva Pharmaceuticals have achieved a significant milestone with the U.S. Food and Drug Administration's (FDA) approval of SIMLANDI (adalimumab-ryvk) injection. This approval positions ... Read More

Orchid Pharma bags FDA approval for Enmetazobactam, first Indian-invented beta lactamase inhibitor

businessnewstoday- February 24, 2024

Chennai-based Orchid Pharma has achieved a significant milestone by receiving approval from the United States Food and Drug Administration (USFDA) for Enmetazobactam, marking a pivotal ... Read More

FDA approves first generic RECTIV ointment by Cosette Pharmaceuticals

businessnewstoday- February 22, 2024

In a landmark move for the pharmaceutical industry, Cosette Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated ... Read More

Immune-Onc Therapeutics gets FDA orphan drug status for IO-202 in CMML

businessnewstoday- February 22, 2024

Immune-Onc Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapies in immunology and oncology, has achieved a significant milestone with the ... Read More

FDA approves Iovance’s AMTAGVI: A breakthrough in melanoma treatment

businessnewstoday- February 18, 2024

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a trailblazer in the field of biotechnology focused on developing novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies, has made ... Read More

Kurome Therapeutics advances with FDA-approved IND for KME-0584 in AML and HR MDS clinical trial

businessnewstoday- February 17, 2024

In a significant development for cancer research, Kurome Therapeutics Inc. has announced the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug ... Read More

FDA advances Sarepta Therapeutics’ ELEVIDYS for Duchenne muscular dystrophy treatment

businessnewstoday- February 17, 2024

In a promising development for the treatment of rare diseases, Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a frontrunner in precision genetic medicine, announced that the U.S. Food ... Read More

FDA grants Otsuka’s Sibeprenlimab breakthrough therapy designation in IgAN

businessnewstoday- February 17, 2024

In a significant development for the treatment of kidney disease, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sibeprenlimab, an ... Read More

FDA approves Genentech’s Xolair for food allergies: A new horizon in allergy treatment

businessnewstoday- February 17, 2024

The U.S. Food and Drug Administration (FDA) has approved Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to foods ... Read More