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A federal court in Delaware has rejected a motion by Hikma Pharmaceuticals to dismiss Amarin Pharma’s patent lawsuit over Hikma’s generic version of the heart drug Vascepa (icosapent ethyl). Read More
Bristol Myers Squibb (BMS) said it plans to withdraw Istodax’s indication as a monotherapy for peripheral T-cell lymphoma (PTCL) after at least one prior therapy. Read More
The Senate Appropriations Committee yesterday voted 25-5 to advance a proposed funding bill that would give the FDA a $200 million boost in nonuser-fee funding in fiscal 2022. Read More
Sanofi drew fire for a product website that offered “inaccurate information about and out-of-date prescribing information” for Dupixent (dupilumab), which is used to treat eczema, asthma and chronic rhinosinusitis. Read More
The FDA has issued a warning letter to Syntec Pharma for failure to prevent cross-contamination and for other good manufacturing practice lapses at its drug facility in Farmingdale, N.Y. Read More
After a satisfactory review of toxicology data, the FDA has given Novartis the green light to test its spinal muscular atrophy (SMA) gene therapy, Zolgensma (AVXS-101), in patients aged two to 18 years. Read More
The FDA yesterday issued a long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device. Read More
Three years after it missed a key endpoint in its first phase 3 trial, AstraZeneca’s monoclonal antibody Saphnelo (anifrolumab-fnia) turned things around and has now garnered FDA approval for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE), the most common form of lupus. Read More
The FDA has abruptly withdrawn a notice that was scheduled to be published in the Federal Register (FR) Tuesday, announcing a sharp increase in the fees for drugmakers under the Prescription Drug User Fee Act (PDUFA). Read More
Monoclonal antibody cocktails could be a useful alternative to rabies immunogloblin (RIG) when that’s in short supply and to avoid the risk of bloodborne contaminants, the FDA said in a new guidance for developers of anti-rabies antibody cocktails. Read More