Shares of Cero Therapeutics Holdings drew increased retail investor chatter on Tuesday after the company said that the FDA ...

Jaguar Health (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD ...

today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil ® (remestemcel-L) for treatment of steroid-refractory ...

(RTTNews) - Mesoblast (MESO, MSB.AX) announced that it has received seven years of orphan-drug exclusive approval from U.S ... exclusivity means that the FDA will not approve another mesenchymal ...

WASHINGTON — Jazz Pharmaceuticals lost its bid to overturn the approval of another company’s rival sleep drug when a D.C. federal judge ruled that the FDA did not violate the Orphan Drug Act when ...

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug ...

News, July 26, 2020 New FDA Orphan Drugs: Gestiva, Onconase, Aerosolized Ciprofloxacin The FDA has approved orphan drug status for a long-acting injectable form of a naturally occurring ...

PYC Therapeutics Limited (AU:PYC) has released an update. PYC Therapeutics has received Orphan Drug Designation from the US FDA for its pioneering drug candidate, VP-001, aimed at treating ...

The Food and Drug Administration (FDA) has granted Orphan Drug designation to LQT ... long QT syndrome deserve a properly studied and FDA-approved therapy to help in their battle against this ...

Crofelemer previously granted orphan-drug designation by the FDA and the ... Napo's crofelemer is FDA-approved under the brand name Mytesi ® for the symptomatic relief of noninfectious diarrhea ...