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In its 2022 Focus Areas of Regulatory Science report released last week, the FDA adds to its list of regulatory priorities research efforts in oncology and rare disease. Read More
In just six pages of final guidance released today, the FDA lays out exactly when and how sponsors should include real-world data and real-world evidence (RWD/RWE) in applications for investigational and new drugs, as well as biologics licenses. Read More
Drugmakers planning to submit investigational drug, new drug or biologics license applications for pediatric drug studies should conduct clinical pharmacology studies using patients with the disease the drug is intended to treat, according to a new draft guidance released by the FDA today. Read More
Two years after issuing a refuse to file (RTF) letter to Y-mAbs regarding Omblastys (omburtamab), the FDA has agreed to hear data supporting the development of the radioisotope-linked antibody designed to deliver targeted radiation to tough-to-treat pediatric brain tumors. Read More
Bayer has agreed to pay $40 million to resolve alleged violations of the False Claims Act (FCA) in connection with three of the company’s drugs, the U.S. Department of Justice (DOJ) said in a statement. Read More
Otsuka Holdings and H. Lundbeck filed another lawsuit in an attempt to stop Viatris (formerly Mylan) from marketing a generic of the injectable version of the antipsychotic drug Abilify Maintena (aripiprazole). Read More
A U.S. District Court in Delaware has decided in favor of United Therapeutics over Liquidia in one of its patent disputes over Tyvaso (treprostinil), a drug used to treat pulmonary arterial hypertension — abnormally high blood pressure in the arteries of the lungs. Read More
A federal judge ruled earlier this week that stem cell therapies are procedures, not drugs, and that the FDA has no jurisdiction over them, blocking the agency’s attempt to regulate the California Stem Cell Treatment Center’s (CSCTC) products. Read More