Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Vincristine Sulfate Injection (ANDA076296) by Fresenius Kabi USA
The FDA approved ANDA076296 for a Vincristine Sulfate injectable (1 mg/mL) submitted by Fresenius Kabi USA. The product is listed as discontinued.
Regulatory Updates
Sep 21, 2026•1 min read
FDA Approves Multiple Novel Therapies in August 2026 Targeting Rare Diseases and Unmet Needs
In August 2026, the FDA granted Novel Drug approval to at least seven new molecules, including treatments for rare diseases, refractory cancers, blood disorders, HIV, gene therapy and an mRNA flu vaccine.
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
Sep 17, 2026•1 min read
Professor Hong Highlights Gaps in Pricing Reform for Chronic Disease Innovative Drugs
Despite focus on rare disease and oncology, Korea's drug price reform still limits innovative treatments for common chronic conditions, says Seoul National University economist.
Regulatory Updates
Sep 16, 2026•1 min read
Experts Call for New Evaluation System for Innovative Cancer Drugs in Korea
At a forum on sustainable healthcare, Professor Ahn Hee‑kyung highlighted bottlenecks in Korean patients’ access to innovative anticancer drugs and urged a valuation framework that includes clinical and socioeconomic benefits.
Regulatory Updates
Sep 15, 2026•1 min read
Korea’s First Domestic CAR‑T Therapy Rimkato Secures Reimbursement Approval, Targeting 2026 Commercial Launch
Qurocell’s CAR‑T product Rimkato (anvalkaptagen autologous cell) has cleared the Cancer Disease Review Committee and the Drug Reimbursement Evaluation Committee, opening the path to health‑insurance coverage and a potential market launch within the year.
Regulatory Updates
Sep 11, 2026•1 min read
Oncogenic Therapeutics Secures US Patent for New Crystal Form and Manufacturing Method of Nesuparib
Oncogenic Therapeutics received a US patent decision for Nesuparib’s high‑purity crystal form and its manufacturing process, extending protection through May 2042 ahead of US clinical trials.
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Regulatory Updates
Sep 10, 2026•1 min read
Revolution Medicines' Daraxonrasib (Rasonque) Receives FDA Approval for Metastatic Pancreatic Cancer
Revolution Medicines' RAS inhibitor daraxonrasib, branded Rasonque, was approved by the FDA for metastatic pancreatic cancer after ASCO data earned a standing ovation.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA077247 for Carboplatin Injectable Products (Discontinued)
FDA approved ANDA077247 for three carboplatin injectable products from Fresenius Kabi USA; all listed strengths are marked discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA approves 26 new drugs in H1 2026, highlighting oral therapies and PROTACs
The FDA cleared 26 new drugs in the first half of 2026, emphasizing a shift to oral treatments and novel modalities like PROTACs, with oncology and neurology leading indications.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Pfizer/Astellas Padcev and Merck Keytruda Combo for All MIBC Patients
The FDA has approved the Padcev and Keytruda combination as the first muscle‑invasive bladder cancer therapy usable irrespective of cisplatin eligibility, for both neoadjuvant and adjuvant settings.
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Regulatory Updates
Sep 1, 2026•1 min read
FDA Approves Sanofi's Subcutaneous Sarclisa Escena for Multiple Myeloma
Sanofi's subcutaneous formulation of Sarclisa, Sarclisa Escena, received FDA approval, becoming the first injectable oncology drug deliverable via on-body injector.