FDA Takes Steps for the Development of Non-Opioid Pain Medications
FDA issuing documents that should lead to smaller clinical trials, faster approvals and quicker launches of nonopioid pain medications.
First Therapy Approved to Treat Rare Blood Clotting Disorder
FDA has approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive
therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura.
FDA Approves Hepatitis A and Measles Exposure Drug
FDA has approved Grifols’ GamaSTAN to treat people exposed to measles and the hepatitis A viruses.
Romiplostim Approved to Treat Pediatric Patients with Immune Thrombocytopenia
FDA has approved Amgen’s romiplostim to treat pediatric patients ages 1 year and older with immune thrombocytopenia for a minimum of six months and who have had an insufficient response to corticosteroids, immune globulin or splenectomy.
FDA Approves Drug to Treat Acute Myeloid Leukemia
FDA has approved Xospata (gilteritinib) to treat adult patients with relapsed or refractory acute myeloid leukemia with a certain genetic mutation.
Tdap Booster Vaccine Receives Expanded FDA Indication
FDA granted Sanofi Pasteur’s Adacel Tdap absorbed vaccine expanded indication to include repeat vaccinations for tetanus, diphtheria and pertussis.
New Hemophilia A Treatment Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved Bayer’s Jivi (BAY94-9027) as a preventive treatment for bleeding in hemophilia A.
Single-Dose Flu Drug Given Priority Review by FDA
Genentech’s baloxavir marboxil, an experimental, single-dose flu drug, has been given priority review by the U.S. Food and Drug Administration (FDA).
Cinryze Approved for Preventing Pediatric Angioedema Attacks
The U.S. Food and Drug Administration (FDA) has approved Shire’s Cinryze (C1 esterase inhibitor [human]) to prevent angioedema attacks in children 6 years and older with hereditary angioedema.
Second JAK Inhibitor Drug for RA Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved Incyte Corp.’s Olumiant (baricitinib) 2 mg once-daily oral medication to treat adults with moderately to severe active rheumatoid arthritis.
