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The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following tumor removal. Read More
Minerva Neurosciences has received a complete response letter (CRL) from the FDA on an NDA for the company’s schizophrenia drug roluperidone. Read More
This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for molecular glue. Read More
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting, including four orphan drugs, one biosimilar and two generics. Read More
In a slowdown for Venatorx Pharmaceuticals, Melinta Therapeutics and the progress of new treatment for adults with complicated urinary tract infections (cUTI), the FDA issued a Complete Response Letter (CRL) for the companies’ NDA for cefepime-taniborbactam. Read More
The FDA is withdrawing its approval of Oncopeptides’ multiple myeloma drug Pepaxto (melphalan flufenamide), effectively ending a three-year tug-of-war over the controversial drug’s future. Read More
This edition of Quick Notes looks at significant drug approvals, including the first cellular therapy for patients with unresectable or metastatic melanoma, a drug to reduce accidental food allergy reactions, Tagrisso with chemotherapy for patients with EGFR-mutated advance lung cancer and a dosage reduction for patients with relapsed or refractory multiple myeloma. Read More
This edition of Quick Notes looks at consequential new drug approvals, including a first drug for frostbite, a first of its kind gene therapy authorization for sickle cell disease and transfusion-dependent beta thalassemia, supplemental approvals for pancreatic and non-small cell lung cancer and a treatment for an inflammatory esophageal condition. Read More
A new non-opioid pain killer holds promise in phase 3 trials, a gene therapy restores hearing lose, a GI cancer trial succeeds, and mushrooms may hold promise in treating pancreatic cancer in this month’s edition of Research Roundup. Read More
Vertex announced FDA approval of Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. Read More
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by University of California San Francisco (UCSF) researchers. Read More