US companies Incyte and Syndax Pharmaceuticals today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), 19 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
Roche today released positive top-line results of the Phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. 19 September 2024
US contract development and manufacturing organization (CDMO) BioCentriq has appointed Syed Husain as its new chief executive (CEO), and as a member of the board of directors. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Upstream Bio, a clinical-stage biotechnology company, has filed for an initial public offering, listing on the Nasdaq under the ticker symbol "UPB." 19 September 2024
Denmark-based Bavarian Nordic and Gavi, the Vaccine Alliance yesterday announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN mpox vaccine (marketed as Jynneos or Imvanex) to be supplied to countries in Africa impacted by the mpox outbreak. 19 September 2024
The atopic dermatitis (AD) market is on track to reach $16.7 billion across mature markets by 2030, according to data and analytics company GlobalData. 19 September 2024
TG Therapeutics yesterday shared new five-year data from the ULTIMATE I & II Phase III trials evaluating Briumvi (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
MAIA Biotechnology, a US biopharmaceutical company developing targeted immunotherapies for cancer, has announced a positive update on its lead clinical candidate. 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
The US Food and Drug Administration (FDA) said on Thursday that it is at a turning point in understanding the science that is opening doors to rare disease treatments that were unthinkable only a few 28 June 2024
TwoStep Therapeutics, a biotech start-up developing targeted therapies for solid tumors, has officially launched after securing $6.5 million in seed funding. 27 June 2024
CASI Pharmaceuticals (Nasdaq: CASI) has announced a preliminary proposal from its chairman and chief executive, Wei-Wu He, to acquire the company's business operations in China. 27 June 2024
The US Department of Health and Human Services (HHS)—through the Centers for Medicare and Medicaid Services (CMS)—has announced that some Medicare enrollees will pay less for 64 drugs available through Medicare Part B. 27 June 2024
Shares of US clinical-stage biotech Vigil Neuroscience
leapt as much as 45% to $5.42 in pre-market activity, on news of a deal with French pharma major Sanofi. 27 June 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan (HER3-DXd). 27 June 2024
It was a milestone achievement when Moderna last month announced its first US Food and Drug Administration (FDA) approval outside COVID-19. 27 June 2024
The UK’s health technology assessor has changed its tune regarding CSL Behring’s Hemgenix (etranacogene dezaparvovec), recommending the product for use in England and Wales. 27 June 2024
Danish diabetes and obesity giant Novo Nordisk yesterday revealed that the CLARION-CKD Phase III trial failed to meet its primary endpoint and will be stopped. 27 June 2024
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued recommendations to tackle shortages of glucagon-like peptide-1 (GLP-1) receptor agonists. 26 June 2024
US RNA specialist Wave Life Sciences has presented positive results from its Phase Ib/IIa SELECT-HD trial of WVE-003, which is being developed as a potential disease modifying therapeutic for Huntington’s disease (HD). 26 June 2024
Braeburn has published a post hoc analysis of data from a Phase III trial of Brixadi (buprenorphine) in the Journal of the American Medical Association (JAMA). 26 June 2024
UCB ( has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for Briviact (brivaracetam). 26 June 2024