FDA News

FDA Advisers Urge Approval of Cangene’s Botulism-Fighting Biologic Citing scarce treatment options for botulism, the FDA’s Blood Products Advisory Committee has recommended approval of Cangene’s botulinum antitoxin derived from equine sources. Efficacy studies of the Canadian company’s Botulism Antitoxin Heptavalent… » Read More

The AP (2/14, Neergaard) reports that the Institute of Medicine on Wednesday released a report that concludes, tackling the "problem of fake drugs will require creating a national drug-tracking system." The IOM's report calling "for putting medications through a chain… » Read More

Cologuard Plus is only noninvasive test to be evaluated head-to-head against an independent fecal immunochemical test, which it significantly outperformed 20,000-participant BLUE-C study included 98 colorectal cancers and reflects racial and ethnic diversity of U.S. Company will host conference call… » Read More

FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older   ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of… » Read More

Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD)   September 7, 2023 at 8:15 AM EDT PDF Version Results… » Read More

Seres Therapeutics and Nestlé Health Science Announce FDA Approval of VOWSTTM (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI   – First and only FDA-approved orally administered microbiota-based therapeutic, validating… » Read More

  CinCor Pharma Announces Positive Topline Data for Phase 2 BrigHtn Trial Evaluating Baxdrostat, its Selective Aldosterone Synthase Inhibitor, in Treatment-Resistant Hypertension August 8, 2022 at 7:00 AM EDT PDF Version Successfully met the primary endpoint in the BrigHtn trial,… » Read More

  Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis August 5, 2022 at 8:50 PM EDT PDF Version Data from the Phase 3 SPIRIT… » Read More

FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older PDF Version First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis Approved for once-daily… » Read More

  Cara Therapeutics Announces Positive Topline Results from KOMFORT Phase 2 Trial of Oral Difelikefalin for the Treatment of Pruritus in Patients with Notalgia Paresthetica   June 30, 2022   – Study achieved primary endpoint of Worst Itch-Numeric Rating Scale… » Read More