FDA Grants Fast Track Designation to Amlenetug As Treatment for Multiple System Atrophy
The designation is based on the AMULET phase 2 trial, which was the first-in-human study of the drug.
FDA Grants Fast Track Designation to Troculeucel for Moderate Alzheimer Disease
Data has shown the investigational cell therapy is well-tolerated in patients and showed preliminary impacts on cognition.
FDA Grants ADI-001 Fast Track Designation as Treatment of Refractory Systemic Lupus Erythematosus
ADI-001 is an investigation allogeneic gamma delta chimeric antigen receptor T cell therapy that targets CD20 for the treatment of a variety of autoimmune diseases.
FDA Grants ABO-101 Orphan Drug, Rare Pediatric Disease Designations for PH1
Primary hyperoxaluria type 1 (PH1) is a rare genetic condition that affects the kidney, bladder, or urinary tract, and indicates high levels of oxalates in the urine.
FDA Approves Ranibizumab Injection for Diabetic Macular Edema
The therapy is now the first and only FDA-approved treatment that maintains vision with fewer treatments compared to standard-of-care injections.
FDA Approves Apomorphine for Treatment of Motor Fluctuations in Parkinson Disease
The drug will be made available in the second quarter of 2025.
FDA Approves Spravato as Monotherapy for Major Depressive Disorder
The approval makes Johnson and Johnson’s esketamine nasal spray the first and only monotherapy for the treatment of major depressive disorder in adult patients.
FDA Clears DASH SARS-CoV-2, Flu A/B Combination Test
Using the DASH Rapid PCR System, providers can yield test results in under 1 minute of hands-on time.
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.
