The FDA is falling under the political spell that “more drugs, and faster” is the best way to serve the healthcare needs of American citizens, according to a new report…
In a new draft guidance released Thursday, the FDA laid out its thinking on developing drugs that treat Clostridioides difficile infection (CDI), as well as those that prevent and reduce…
The FDA scolded Jubilant Pharma for failing to properly investigate batch discrepancies and keep written records, among other deficiencies, during an inspection of its Indian facility in Sikanderpur Bhainswal, Uttaranchal…
Acadia Pharmaceuticals has filed three separate patent infringement suits in an attempt to block generic formulations of its only approved drug, Nuplazid (pimavanserin). Source: Drug Industry Daily
As part of its commitments under the recently reauthorized Generic Drug User Fee Amendments (GDUFA), the FDA has set out a list of eight science and research priorities for generics…
The FDA is pushing off or rescheduling several advisory committee meetings this week — including one to consider what could become of the first over-the-counter (OTC) daily oral contraceptive in…
Drug manufacturer and outsourcer Nephron SC failed to adequately investigate incidents of cross-contamination between its outsourced operations and its conventional manufacturing line, said the FDA in an especially lengthy and…
AstraZeneca’s blockbuster Fasenra (benralizumab) has stumbled in its quest to become a therapy for eosinophilic esophagitis, failing to hit the clinical target of its dual-primary endpoints in a critical phase…
The World Health Organization (WHO) should include drugs on its essential medicines list regardless of their cost, according to a group of researchers that advocates separating reviews of comparative effectiveness,…
On the heels of a recent FDA write-up, another Catalent facility drew a Form 483 from the agency for multiple quality lapses following an inspection of its Brussels, Belgium, plant.…