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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The FDA has abruptly withdrawn a notice that was scheduled to be published in the Federal Register (FR) Tuesday, announcing a sharp increase in the fees for drugmakers under the Prescription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The Federal Trade Commission (FTC) has withdrawn the last count in its complaint against drugmaker AbbVie after the Supreme Court declined to review a ruling that the drugmaker used sham litigation to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
The FDA issued an advisory to drugmakers about the risk of bacterial contamination of non-sterile water-based drug products by Burkholderia cepacian (BCC). Read More