ANTIEPILEPTIC DRUG FYCOMPA® INJECTION FORMULATION APPROVED IN JAPAN
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has obtained marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for the injection…
WuXi Biologics Granted U.S. Patent for Proprietary Bispecific Antibody Technology Platform WuXiBodyTM
WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that a patent for WuXiBodyTM – a proprietary, highly flexible engineering platform that greatly…
New Eylea™ 8 mg approved in Japan
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted market authorization for Eylea™ 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD)…
Zoetis Wins 2024 Catalyst Award
Zoetis Inc. (NYSE:ZTS) has been selected as a 2024 Catalyst Award recipient for its global initiative, Awareness and Action Drives Impact, that is advancing equity for women and other underrepresented groups across the…
Bristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers
Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from January 25-27 in…
Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors
Novartis today presented data from the Phase III NETTER-2 trial showing that Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus long-acting release (LAR) octreotide reduced the risk…
Imfinzi plus transarterial chemoembolisation and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolisation
Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free…
Voydeya granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy
Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). It is indicated in Japan in combination with C5 inhibitor therapy when patients have had an…
U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy
Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy…
DUPIXENT® U.S. LABEL UPDATED WITH DATA FURTHER SUPPORTING USE IN ATOPIC DERMATITIS WITH MODERATE-TO-SEVERE HAND AND FOOT INVOLVEMENT
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients…
Swissmedic Authorises CSL’s HEMGENIX®as First Gene Therapy for Hemophilia B
Global biotechnology leader CSL (ASX: CSL) today announced that Swissmedic has authorised HEMGENIX® (etranacogene dezaparvovec), the first and currently only gene therapy for the treatment of male adults aged >18 years with…
European Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous…