Tag: FDA approval
Pfizer secures FDA approval for Hemophilia B gene therapy BEQVEZ
Pfizer Inc. (NYSE: PFE) announced a significant breakthrough in hemophilia treatment with the U.S. Food and Drug Administration's approval of BEQVEZ (fidanacogene elaparvovec-dzkt), a pioneering ... Read More
FDA approves Medtronic’s innovative spinal cord stimulator for chronic pain treatment
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced a significant advancement in the treatment of chronic pain with the U.S. Food ... Read More
FDA approves Alvotech and Teva Pharmaceuticals’ SELARSDI as biosimilar to Stelara
In a significant development in the pharmaceutical industry, Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: ... Read More
Bristol Myers Squibb announces success of KRAZATI in Phase 3 KRYSTAL-12 study
Bristol Myers Squibb (NYSE: BMY) has reached a pivotal milestone in the treatment of non-small cell lung cancer (NSCLC) with its announcement regarding the KRYSTAL-12 ... Read More
FDA approves Akebia Therapeutics’ Vafseo for anemia in dialysis patients
In a significant development for the treatment of anemia related to chronic kidney disease (CKD) in dialysis patients, Akebia Therapeutics, Inc. (Nasdaq: AKBA), a pioneering ... Read More
FDA grants full approval to AbbVie’s ovarian cancer drug ELAHERE
AbbVie (NYSE: ABBV) has achieved a significant milestone in the fight against ovarian cancer with the U.S. Food and Drug Administration (FDA) granting full approval ... Read More
LENZ Therapeutics announces merger with Graphite Bio to revolutionize presbyopia treatment
In a significant move for the biopharmaceutical industry, LENZ Therapeutics, Inc. (Nasdaq: LENZ), a trailblazer in developing innovative treatments for presbyopia, announced the successful completion ... Read More
FDA approves Italfarmaco’s Duvyzat for duchenne muscular dystrophy treatment
In a significant advancement for the treatment of Duchenne muscular dystrophy (DMD), Italfarmaco S.p.A. has announced the U.S. Food and Drug Administration (FDA) approval of ... Read More
FDA approves expansive label updates for Esperion’s NEXLETOL and NEXLIZET
In a significant advancement for heart health management, Esperion (NASDAQ: ESPR) has announced that the United States Food and Drug Administration (FDA) has approved comprehensive ... Read More
Celltrion USA launches ZYMFENTRA for ulcerative colitis and Crohn’s disease
In a significant advancement for patients with digestive disorders, Celltrion USA has announced the availability of ZYMFENTRA (infliximab-dyyb), marking it as the first and only ... Read More