FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity
Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.
FDA Updates Veozah Label With Boxed Warning for Rare But Serious Liver Injury
The patient’s symptoms gradually resolved after discontinuing fezolinetant therapy.
Tapinarof Cream 1% Approved by FDA to Treat Atopic Dermatitis in Adults, Children 2 Years and Older
Vtama from Organon was previously approved in May 2022 to treat plaque psoriasis in adults.
FDA Roundup: ATX101 Gains Breakthrough Therapy Designation, Stelara Biosimilar Approval
Catch up on important FDA news from the week of December 2.
FDA Approves Acoramidis for ATTR-CM
This approval marks the availability of the first near-complete stabilizer of transthyretin.
FDA Accepts BLA Resubmission for Epidermolysis Bullosa Gene Therapy
The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.
FDA Roundup: Rosacea Treatment, Proposal to Remove Oral Phenylephrine from OTC Products
Check out these important FDA updates from the week of November 4.
Lumateperone Demonstrates Efficacy in Reducing Symptomatic Relapse Risk in Schizophrenia
The drug is also approved to treat schizophrenia and bipolar depression.
FDA Approves Journey Medical’s Emrosi for Rosacea
“Emrosi has potential to become the best-in-class oral medication to treat the condition,” said the CEO of Journey Medical.
FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics
The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.
FDA Roundup: Agency Highlights from October 2024
Check out these important FDA updates from the month of October 2024.
FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain
The addition of a 10 mg oxycodone hydrochloride tablet improves dosing flexibility and precision.
FDA Approves Sulopenem Etzadroxil and Probenecid for Uncomplicated UTIs
The FDA has approved just the second treatment for uncomplicated urinary tract infections (UTIs) in the last 2 decades.
FDA Approves Abrysvo for Adults 18-59 at Increased Risk for RSV
Abrysvo is the only RSV vaccine approved for use in this age group.
Gepotidacin NDA Under Priority Review by FDA for Uncomplicated UTI
Gepotidacin is a first-in-class oral antibiotic with a novel mechanism of action.
FDA Approves Ensifentrine, Novel Treatment for Chronic Obstructive Pulmonary Disease
On June 26, 2024, the FDA approved ensifentrine (Ohtuvayre) for the treatment of COPD.
FDA Approves Ceftobiprole Medocaril Sodium for 3 Indications
The FDA approved ceftobiprole medocaril sodium for injection (Zevtera) in April 2024.
FDA Roundup: Hemophilia B Therapy, Stelara Biosimilar Approval
Check out important updates from the FDA for the week of October 7.
FDA Approves First Weekly Subcutaneous Therapy for Hemophilia B
Marstacimab-hncq is the first non-factor and once-weekly treatment available for patients with hemophilia B and promises to reduce the burden of care.
FDA Approves Imuldosa, Biosimilar to Stelara
The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.
FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms
The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.
FDA Roundup: Biosimilar Approval, Hereditary Angioedema Treatment Receives Orphan Drug Designation
Check out important updates from the FDA for the week of September 30.
FDA Roundup: Agency Highlights from September 2024
Check out these important FDA updates from the month of September 2024.
FDA Approves Dupixent as First Biologic Treatment for COPD
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways.
Schizophrenia Drug Approved by FDA Represents First New Treatment Option in Decades
The approval of xanomeline and trospium chloride (Cobenfy) from Bristol Myers Squibb represents a “transformative moment in the treatment of schizophrenia.”
FDA Approves Levacetylleucine for Treatment of Niemann-Pick Disease Type C
The approval comes shortly after the FDA approved arimoclomol from Zevra Therapeutics to treat neurological manifestations of the disease in combination with miglustat.
FDA, CDC: E-Cigarette Use Among Youth Continues to Plummet
Initiatives such as media campaigns and legislative rulings by the agencies have likely contributed to the decline.
FDA Approves First Treatment for Niemann-Pick Disease Type C
Zevra Therapeutics said it expects the therapy to be commercially available in the United States in 8 to 12 weeks.
Breaking: FDA Approves FluMist as First-Ever Self-, Caregiver-Administered Flu Vaccine
The vaccine will be made available via third-party online pharmacies.
FDA Roundup: First 1-Year CGM, Lebrikizumab-lbkz for Atopic Dermatitis
Check out important updates from the FDA for the week of September 16.
