HER2-positive breast cancer.
Oct 17, 2025
Seagen’s TUKYSA Powers Pfizer’s Next HER2-Positive Breast Cancer Milestone
Pfizer’s oncology pipeline has achieved a second positive phase III trial in HER2-positive breast cancer within roughly a year. This latest success involves TUKYSA, a HER2-targeted tyrosine kinase inhibitor that Pfizer acquired through its $43 billion purchase of Seagen. In patients with HER2-positive metastatic...
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Sep 16, 2025
Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia
Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib/II clinical trials in patients with chronic hepatitis B (CHB). The ...
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Aug 09, 2022
FDA Approves AstraZeneca’s Enhertu; Bayer Wins FDA Approval for Prostate Cancer Therapy, Nubeqa; Gilead Sciences to Acquire MiroBio; AstraZeneca & Merck’s Lynparza Gets EU Approval; Pfizer to Acquire Global Blood Therapeutics; Sironax Raises USD 200 Million
FDA Approves AstraZeneca’s Enhertu as First Targeted Therapy for HER2-low Cancer Enhertu, developed by AstraZeneca and Daiichi Sankyo, has been approved by the FDA as the first targeted therapy for HER2-low breast cancer, a new subtype of the disease previously categorized as HER2-negative. It has the potential ...
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Jun 30, 2020
FDA’s No to Intercept’s NASH Drug; Roche’s Phesgo gets approval; Gilead’s Remdesivir pricing
Intercept Pharmaceuticals receives a clear rejection from the FDA for its NASH drug, Obeticholic acid (OCA) Intercept Pharmaceuticals announced the issuance of a Complete Response Letter (CRL) by the FDA regarding the New Drug Application (NDA) for Obeticholic acid (OCA) for the treatment of fibrosis due to ...
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