(RTTNews) – 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.
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.
Ishihara Sangyo Kaisha Ltd.’s Panoquell-CA1, the first drug to manage acute onset of pancreatitis in dogs, secured conditional FDA approval on Nov.15. Fuzapladib sodium is the active ingredient in Panoquell.
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.
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.
Provention Bio’s Tzield secured FDA nod on Nov.17, becoming the first drug that can delay the onset of Type 1 diabetes.
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.
Now, let’s take a look at the biotech stocks facing FDA decision in December.
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