Bayer secures FDA approval for hemophilia A treatment drug Jivi
In a major advancement for hemophilia A therapy, Bayer's recombinant factor VIII (rFVIII) replacement therapy, Jivi (BAY94-9027), has received approval from the U.S. Food and ... Read More
Janssen Pharmaceutical’s IMBRUVICA and Rituximab combo wins FDA approval for waldenström’s macroglobulinemia treatment
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has received approval from the US Food and Drug Administration (FDA) for its combination treatment of IMBRUVICA ... Read More
Ortho Dermatologics’ Altreno lotion gets FDA approval for Acne treatment
Ortho Dermatologics, a division of Bausch Health Companies, has achieved a significant milestone with the FDA approval of Altreno lotion (tretinoin 0.05%) for the treatment ... Read More
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