Browsing Tag
FDA approval
131 posts
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…