Senores Pharmaceuticals expands US footprint with Roflumilast ANDA acquisition
Senores Pharmaceuticals Limited has taken a significant step in its US expansion strategy by acquiring an Abbreviated New Drug Application (ANDA) for Roflumilast 250 mcg ... Read More
Lupin shocks the market with massive profit gains in Q3 FY2025—here’s what you need to know
Lupin Limited, a leading global pharmaceutical company, has reported strong financial results for the third quarter of fiscal year 2025, reflecting its strategic focus on ... Read More
FDA authorizes Virtual Incision’s MIRA: A leap forward in robotic-assisted surgery
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
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
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
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
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
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
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
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