FDA Grants Emergency Authorization to Aptitude’s COVID, Flu Test
The next-gen molecular Metrix was given emergency use authorization for its ability to test for SARS-CoV-2 and influenza A and B viruses.
FDA Approves Updated Buprenorphine Label For Rapid Initiation Treatment
The updated label also includes alternative injection sites, such as the abdomen, thigh, buttock, or back of the upper arm.
FDA Approves Chenodiol for Treatment of Cerebrotendinous Xanthomatosis
Ctexli is the first FDA-approved treatment for adults with cerebrotendinous xanthomatosis.
FDA Says Ozempic, Wegovy Shortage Resolved
Semaglutide has been in shortage since 2022 due to increased demand.
FDA Grants Breakthrough Therapy Designation to SkinTE for Wagner Grade 1 Diabetic Foot Ulcers
By 12 weeks, investigators report that SkinTE facilitated significantly more wound closures compared with the standard of care.
FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia
The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.
FDA to Evaluate Lenacapavir for Prevention of HIV
A PDUFA target action date for the PrEP therapy has been set for June 19, 2025.
FDA Accepts sBLA for Dupilumab for Bullous Pemphigoid
Previously, dupilumab (Dupixent) received orphan drug designation for bullous pemphigoid.
FDA Approves Recombinant Chikungunya Vaccine, Vimkunya
The vaccine is the first virus-like particle single-dose vaccine for chikungunya for patients 12 years and older.
FDA Approves Denosumab-Dssb as Biosimilar for Prolia, Xgeva
Denosumab-dssb is approved as a 60 mg pre-filled syringe as a biosimilar for Prolia and 120 mg vial as a biosimilar for Xgeva.
FDA Approves MenABCWY Vaccine for Patients Ages 10 to 25 Years
The combination includes 2 previously approved vaccines to target the 5 major serogroups of Neisseria meningitidis.
FDA Grants Fast Track Designation to Cannabis Withdrawal Syndrome Therapy
A dose response is observed with the highest dose of the drug and mitigating withdrawal symptoms for patients with cannabis use disorder.
FDA Approves Risdiplam Tablet for Spinal Muscular Atrophy
The tablet formation of risdiplam (Evrysdi) demonstrates bioequivalence to the oral formulation of the drug.
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.
