Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves AstraZeneca ISOETHARINE Inhalation (ANDA089615)
The FDA approved ANDA089615 for ISOETHARINE HYDROCHLORIDE inhalation solution (0.125%) by AstraZeneca. The product is listed as discontinued.
Regulatory Updates
Sep 21, 2026•1 min read
FDA Grants Accelerated Approval to AstraZeneca’s Oral SERD Etcamah for HR‑Positive/HER2‑Negative Breast Cancer
The US FDA approved AstraZeneca’s oral SERD camizestrant, branded Etcamah, for HR‑positive/HER2‑negative breast cancer patients with ESR1‑mutated ctDNA detected before radiographic progression, based on the Phase 3 SERENA‑6 trial.
Regulatory Updates
Sep 21, 2026•1 min read
UK R&D rebate hike prompts AstraZeneca, Merck to pull investment plans
A year after the UK raised NHS rebate rates on new branded medicines to 31.3%, AstraZeneca and Merck withdrew planned R&D investments, citing a challenging innovation environment.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Priority Approval for AstraZeneca's IMFINZI (Durvalumab) BLA761069
The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.
Regulatory Updates
Aug 27, 2026•1 min read
AstraZeneca to Pay $34M to Settle Texas Medicaid Kickback Lawsuit
AstraZeneca agreed to pay $34 million to resolve a lawsuit alleging illegal kickbacks to induce Medicaid prescriptions in Texas.
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