Approvals
VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.
Friday morning, the FDA granted Emergency Use Authorization to both Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in children ages 6 months to 4 years old.
The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).
The FDA has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.
Eli Lilly’s Olumiant (baricitinib) received approval from the FDA for the treatment of severe alopecia areata, making it the first systemic treatment for adults living with the disease.
ION582 is uniquely formulated using RNA technology to provide relief to patients with Angelman syndrome, a rare disorder for which limited treatment options are available.
The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
Shares of TG Therapeutics are falling fast in Wednesday trading after the U.S. Food and Drug Administration announced it was pulling approval of the cancer drug Ukoniq (umbralisib).
PRESS RELEASES