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Sanofi drew fire for a product website that offered “inaccurate information about and out-of-date prescribing information” for Dupixent (dupilumab), which is used to treat eczema, asthma and chronic rhinosinusitis.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The FDA has abruptly withdrawn a notice that was scheduled to be published in the Federal Register (FR) Tuesday, announcing a sharp increase in the fees for drugmakers under the Prescription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
The Federal Trade Commission (FTC) has withdrawn the last count in its complaint against drugmaker AbbVie after the Supreme Court declined to review a ruling that the drugmaker used sham litigation to illegally maintain a monopoly on its testosterone drug AndroGel. Read More
Emergent BioSolutions, which botched 75 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine, has said publicly for the first time that it has gotten records requests from a slew of federal investigators related to its COVID-19 contracts. Read More
Developing a good working relationship with your regulatory project manager (RPM) at the FDA is “the single most important thing you can do” to improve communication during a regulatory review, an agency official said at the FDA’s Regulatory Education for Industry Annual Conference. Read More