Seres Therapeutics has secured priority review designation from the US Food and Drug Administration (FDA) for SER-109, its investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection (rCDI). The biologics license application (BLA) of the American microbiome therapeutics company for SER-109 has been given a prescription drug user fee act (PDUFA) action […]
Nestlé will take full ownership of Aimmune Therapeutics, the developer of FDA approved peanut allergy drug Palforzia, by acquiring the remaining stake of 74.4% in the latter for about $2 billion. The deal is expected to help the Swiss conglomerate’s subsidiary Nestlé Health Science and Aimmune Therapeutics to create a global leader in the prevention […]
Aimmune Therapeutics said that the first patients in the US are being treated with the recently FDA approved peanut allergy drug PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. The California-based biopharma company said that specialty pharmacies are shipping initial dosing kits of the new peanut allergy drug to allergists for in-office administration to their peanut-allergic patients […]
Aimmune Therapeutics, which has recently bagged approval from the US Food and Drug Administration (FDA) for its peanut allergy drug PALFORZIA (formerly AR101), has secured an additional equity investment of $200 million from Nestlé Health Science. Based in California, Aimmune Therapeutics has been focused on the development and commercialization of treatments for potentially life-threatening food […]
Palforzia FDA approval : Aimmune Therapeutics has been granted approval from the US Food and Drug Administration (FDA) for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for the treatment of peanut allergy in children. The peanut allergy drug has been approved for mitigating allergic reactions such as anaphylaxis, that may result from accidental exposure to peanuts, […]