AstraZeneca’s Tagrisso (osimertinib) has received U.S. approval for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation…
Bristol Myers Squibb (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for treating schizophrenia in adults. This marks the first new class of schizophrenia treatment in…
Fujirebio has announced that its subsidiary, Fujirebio Diagnostics, Inc., has submitted the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test to the U.S. Food and Drug Administration (FDA) for approval. This new plasma test is poised to…
Takeda (TSE:4502/NYSE) has announced that the Japanese Ministry of Health, Labour and Welfare has approved the manufacture and marketing of FRUZAQLA Capsules (1mg/5mg), containing fruquintinib, a selective oral inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3.…
Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) have announced that Zenyaku has received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the intravenous injection of Rituxan® (rituximab, genetic recombination) in…
The Ministry of Health, Labour and Welfare of Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL injection for IV infusion every four weeks), Eli Lilly and Company’s (NYSE: LLY) treatment for early symptomatic Alzheimer’s disease (AD). This includes patients with…
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that it has filed for regulatory approval to launch a Phase 1/2a clinical trial for ARO-INHBE, its investigational RNA interference (RNAi) therapeutic aimed at treating obesity. The company also plans to seek regulatory…
Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven biotech company focused on developing targeted cancer therapies through its proprietary RADR® AI and machine learning platform, announced that the FDA has granted it three Rare Pediatric Disease Designations (RPDD). These designations cover…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the World Health Organization (WHO) has included dual-stain cytology testing in its updated cervical cancer prevention guidelines. The Roche CINtec® PLUS Cytology test is currently the only FDA-approved and CE-marked dual-stain test…
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for their Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2). This…
Ipsen (Euronext: IPN; ADR: IPSEY) has announced that the European Commission has granted conditional approval for Iqirvo® (elafibranor) 80mg tablets. Iqirvo is approved for the treatment of primary biliary cholangitis (PBC) in adults, either in combination with ursodeoxycholic acid (UDCA)…
Elanco Animal Health Incorporated (NYSE: ELAN) has announced that the U.S. Food and Drug Administration (FDA) has approved Zenrelia™, a once-daily oral JAK inhibitor for the control of pruritus (itching) caused by allergic dermatitis and atopic dermatitis in dogs 12…