The latest FDA drug approvals include traditional approval of pralsetinib for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, a monoclonal antibody for infants and children at severe risk…
The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially…
Texas has settled with Takeda Pharmaceuticals and Baxter International for $42 million over allegations the companies provided kickbacks to Medicaid providers to recommend prescription medications including the attention deficit hyperactivity…
Cybersecurity patches — both proactive to address potential threats and reactive to respond to threats that have already occurred — can be expected to be part of any connected device’s…
Formycon and Fresenius Kabi’s FYB202 will be among the first Stelara (ustekinumab) biosimilars to launch, after the makers reached a legal settlement with Johnson & Johnson, whose patent on the…
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment…
The big three drug associations, representing brand pharmaceuticals, generics and biotechnology, have all expressed strong objections to the CMS proposed rule for the Medicaid Drug Rebate program “stacking” requirement that…
Nektar Pharmaceuticals has launched a two-pronged attack on Eli Lilly: A legal filing charging that Lilly intentionally sabotaged its development of Rezpeg, an investigational biologic the companies were co-developing for…
Gingko Bioworks announced a new $490 million collaboration with Merck to improve Merck’s biologics production efficiency and increase yields. Source: Drug Industry Daily
Vistagen’s fasedienol (PH94B) nasal spray for social anxiety disorder (SAD) showed a statistically significant reduction in anxiety measures during a public speaking challenge, using a measure of subjective units of…