Sun Pharmaceutical Industries gains FDA approval for CEQUA to treat dry eye disease
Sun Pharmaceutical Industries Ltd. has received approval from the U.S. Food and Drug Administration (FDA) for CEQUA (cyclosporine ophthalmic solution) 0.09%, a significant advancement in ... Read More
FDA approves updated label for Regeneron’s EYLEA treating wet AMD
In a significant development for ophthalmic care, Regeneron Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License ... Read More
FDA approves Eisai and Merck’s Lenvima for first-line treatment of liver cancer
In a significant development for cancer treatment, Eisai and Merck have announced that the U.S. Food and Drug Administration (FDA) has approved Lenvima (lenvatinib) for ... Read More
FDA approves Agios Pharmaceuticals’ Tibsovo for targeted acute myeloid leukemia treatment
The US Food and Drug Administration (FDA) has granted approval to Agios Pharmaceuticals for Tibsovo (ivosidenib), designed for the treatment of acute myeloid leukemia (AML) ... Read More
Pfizer receives FDA approval for Nivestym, a Neutropenia biosimilar
Pfizer Inc. has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for Nivestym (filgrastim-aafi), a biosimilar to Amgen's Neupogen ... Read More
FDA approves Agios Pharmaceuticals’ TIBSOVO for acute myeloid leukemia
The US Food and Drug Administration (FDA) has granted approval to Agios Pharmaceuticals’ TIBSOVO (ivosidenib) for the treatment of adult patients with acute myeloid leukemia ... Read More
Amgen and UCB resubmit BLA for EVENITY to transform osteoporosis treatment in postmenopausal women
Amgen, in collaboration with UCB, has announced the resubmission of the biologics license application (BLA) for their osteoporosis drug candidate, EVENITY (romosozumab), to the US ... Read More
FDA sets review date for Ironshore Pharmaceuticals’ ADHD drug HLD200
Ironshore Pharmaceuticals & Development, a subsidiary of Highland Therapeutics, has reached a significant milestone with the U.S. Food and Drug Administration’s (FDA) acceptance of their ... Read More
FDA approves Luxturna gene therapy for inherited vision loss
In a significant advancement for medical science, Luxturna (voretigene neparvovec), developed by Spark Therapeutics, has been approved by the U.S. Food and Drug Administration (FDA) ... Read More
Mylan launches generic Estradiol Vaginal Cream after securing FDA approval
Mylan, a global pharmaceutical company, has recently announced the U.S. Food and Drug Administration (FDA) approval of its Estradiol Vaginal Cream USP, 0.01%, a generic ... Read More