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Astellas Pharma
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Pharmaceutical
Japanese drug major Astellas Pharma has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval of fezolinetant, a NK3 receptor antagonist, for the treatment of vasomotor symptoms (VMS, also known as hot flushes and sweating) associated with menopause. 8 August 2026
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A South Korean biotechnology company developing next-generation biobetters and biosimilars through proprietary platform technologies, with its human hyaluronidase ALT-B4 attracting a growing roster of global pharmaceutical partners.
Latest News & Features of interest to Astellas Pharma
Biotechnology
Sino-American oncology-focused biotech BeOne Medicines has announced positive top-line results from the second interim analysis (IA2) of the Phase III HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab), in combination with chemotherapy, with and without Tevimbra (tislelizumab), as first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). 1 September 2026
Biotechnology
Swiss pharma giant Novartis said its Phase III REMODEL-1 and REMODEL-2 trials of remibrutinib met their primary endpoint, significantly reducing annualized relapse rate compared with teriflunomide in adults with relapsing multiple sclerosis (RMS), according to top-line results announced Tuesday. 1 September 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved Stelara (ustekinumab) injection for moderately to severely active ulcerative colitis (UC) in pediatric patients aged two years and older, the agency's Center for Drug Evaluation and Research said. 1 September 2026
Biotechnology
The European Commission (EC) has approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, Anglo-Swedish firm AstraZeneca and its Japanese partner Daiichi Sankyo announced. 1 September 2026
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) has approved an updated indication for UK pharma major AstraZeneca’s Truqap (capivasertib) following evaluation of additional clinical data submitted after the medicine's initial registration. 1 September 2026
Biotechnology
USA-based infectious disease biotech firm EIT Pharma has closed an oversubscribed $35 million series A round, led by Propel Bio Partners with participation from Good Ventures, Arrowtown and others. The Kirkland, Washington company said the money will principally support its lead candidate, the oral chronic hepatitis D therapy lonafarnib. 1 September 2026
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca and Hong Kong-based biopharmaceutical firm HUTCHMED have reported positive top-line results from a Phase III study of their all-oral lung cancer combination in previously untreated patients in China, opening a route into the first-line setting. 1 September 2026
Generics
RedHill Biopharma on Monday announced the divestment of its 70% stake in the Talicia business to a subsidiary of Apotex Health for an upfront payment of $18 million plus up to an additional $35 million in potential payments based on worldwide net sales milestones. 1 September 2026
Biotechnology
US biotech major Amgen has announced new findings showing Repatha (evolocumab) reduced the risk of death in high-risk adults without a prior heart attack or stroke when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments. 1 September 2026
Biotechnology
German pharma major Bayer’s wholly-owned and independently operated subsidiary AskBio has announced the presentation of baseline participant characteristics from GenePHIT, one of the largest randomized gene therapy trials conducted in heart failure to date. 1 September 2026
Latest In Brief for Astellas Pharma
Pharmaceutical
Spanish drugmaker PharmaMar has announced that health authorities in Canada, Qatar and South Korea have approved Zepzelca (lurbinectedin) in combination with atezolizumab (Roche’s Tecentriq) for the maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin and etoposide. 25 August 2026
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