As we wind down another month, let’s take a look at some of the news stories that made headlines on the regulatory front in November.<\/p>\n
On November 15, the FDA announced a preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use. The move is seen as a part of the regulatory agency’s ongoing attempts to fight the opioid overdose issue by helping expand access to naloxone, a medicine that can help reduce opioid overdose deaths. <\/p>\n
Ishihara Sangyo Kaisha Ltd.’s Panoquell-CA1, the first drug to manage acute onset of pancreatitis in dogs, secured conditional FDA approval<\/span> on Nov.15. Fuzapladib sodium is the active ingredient in Panoquell.<\/p>\n At a time when the world is experiencing a food revolution, there is no better time than now for lab-grown meat to be relevant. <\/p>\n On Nov.16, the FDA completed evaluating the information provided by UPSIDE Foods for cultivated chicken made from cultured chicken cells. This marks the U.S. regulatory agency’s first pre-market consultation of a human food made from cultured animal cells. <\/p>\n Provention Bio’s Tzield secured FDA nod on Nov.17, becoming the first drug that can delay the onset of Type 1 diabetes.<\/p>\n Although gene therapy for hemophilia has been in development for more than two decades, it became a reality on Nov.22, with the FDA’s approval of CSL Behring’s Hemgenix, an adeno-associated virus vector-based gene therapy, for the treatment of adults with Hemophilia B. <\/p>\n Now, let’s take a look at the biotech stocks facing FDA decision in December. <\/p>\n