CLINICAL ROLE -
FDA Annual Flu Vaccine Meeting and CDC’s ‘Wild to Mild’ Campaign Canceled
The decisions were made amid the United States worst flu outbreak in over 2 decades.
Google’s Pixel Watch 3 Loss of Pulse Detection Feature Receives FDA Clearance
The feature is expected to be available to US users in late March 2025.
Novel Porosome Reconstitution Therapy Receives Orphan Drug Designation for Treatment of Cystic Fibrosis
The advanced therapy yielded superior enhanced mucus secretion compared with available therapies.
FDA Approves Odactra Label Expansion to Include Children With House Dust Mite Allergy
The updated indication now includes pediatric patients aged 5 through 11 years.
FDA Ends Semaglutide Shortage Listing, Contributing to Ongoing Legal Challenges
Pharmacies could still experience localized availability issues for semaglutide despite its removal from the drug shortage list.
FDA Approves Miudella, First Hormone-Free, Copper IUD in Over 40 Years
The newly-approved intrauterine device (IUD) prevents pregnancy in people of reproductive potential for up to 3 years.
Pembrolizumab Plus Standard of Care Receives Priority Review for Resectable Locally Advanced Head and Neck Cancer
Pembrolizumab is a humanized monoclonal antibody that targets PD-1.
Cobenfy From Bristol Myers Squibb
FDA OKs Label Changes for Buprenorphine Injections, Reducing Time to Treatment in Opioid Use Disorder
The label changes to buprenorphine extended-release injections can increase convenience and adherence for patients with moderate to severe opioid use disorder.
FDA Accepts New Drug Application for Dordaviprone to Treat Recurrent H3 K27M-Mutant Diffuse Glioma
The designation is supported by pooled data from 4 clinical trials.
Molecular COVID-19/Flu Multiplex Test Is Granted FDA Emergency Use Authorization
The test results are available in as little as 20 minutes.
FDA Grants Fast Track Designation to BRTX-100 to Treat Chronic Lumbar Disc Disease
Currently, the agent is undergoing evaluation in a phase 2 clinical trial to determine its safety and efficacy.
FDA Grants Breakthrough Therapy Designation to SkinTE for Diabetic Foot Ulcers
SkinTE could aid Wagner grade 1 diabetic foot ulcers by regenerating and activating the tissues surrounding the wound to heal it completely.
Chenodiol, First Treatment for Cerebrotendinous Xanthomatosis, Receives FDA Approval
This marks the first FDA-approved treatment for this rare lipid storage disease.
FDA Grants Fast Track Designation to 67Cu-SAR-bisPSMA for Prostate Cancer
67Cu-SAR-bisPSMA is indicated for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
FDA Grants Priority Review to Zongertinib for Treatment of HER2-Mutated, Advanced Non-Small Cell Lung Cancer
Priority review status will allow for expedited development of zongertinib, putting it on the path toward approval as the first in a new class of drugs for mutated NSCLC.
FDA Approves Biosimilar Denosumab-dssb to Treat Osteoporosis-, Cancer-Related Bone Loss
The approval in multiple indications is designed to improve access to effective, proven treatments for skeletal fractures, which can greatly reduce patient quality of life.
5-in-1 Meningococcal ABCWY Vaccine Candidate Receives FDA Approval for Meningococcal Disease
Invasive meningococcal disease is a severe bacterial infection caused by the bacterium Neisseria meningitidis, often leading to meningitis or sepsis.
FDA Grants Fast Track Designation to Amlenetug for Possible Treatment of Multiple System Atrophy
Amlenetug could provide a treatment option for patients with multiple system atrophy, a progressive and rare condition that causes damage to the brain’s nerve cells.
Rapid-Acting Insulin Biosimilar Receives FDA Approval for Diabetes
Insulin-aspart-szjj (Merilog) is the first rapid-acting insulin biosimilar product approved by the FDA.
FDA Approves Vimseltinib for the Treatment of Adults With Symptomatic TGCT
The indication is for symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
Potential Drug for Mitigation of Cannabis Withdrawal Symptoms Receives FDA Fast Track Designation
PP-01 could become a first-in-class treatment for patients with cannabis use disorder.
CUSP06 Granted FDA Fast Track Designation for Patients With Platinum-Resistant Ovarian Cancer
Currently, the Cadherin-6 targeting antibody-drug conjugate is undergoing evaluation in a phase 1a/1b clinical trial.
FDA Accepts BLA for Lerodalcibep, a Novel Agent to Lower LDL Cholesterol in Atherosclerotic Cardiovascular Disease
The agency will now review the novel PCSK9 inhibitor for possible approval in patients with or at high risk of atherosclerotic cardiovascular disease.
FDA Grants Fast Track Designation to Amezalpat for Treatment of Hepatocellular Carcinoma
Building on a previously granted orphan drug designation, the latest FDA action for amezalpat puts the drug in a position for regulatory approval.
Expanded Label for Avacincaptad Pegol Intravitreal Solution Receives FDA Approval
Avacincaptad pegol intravitreal solution is a prescription eye injection used to treat geographic atrophy.
Risdiplam Receives FDA Approval for Spinal Muscular Atrophy
Risdiplam is the only approved non-invasive disease-modifying SMA treatment.
Brentuximab Vedotin Plus Lenalidomide and Rituximab Receives FDA Approval for Adults With LBCL
The approval follows the ECHELON-3 study, which enrolled adults with relapsed or refractory large B-cell lymphoma.
FDA Approves Mirdametinib for Treatment of Adults, Children With NF1-PN
The approval is based on positive clinical trial results that indicated deep and durable reductions in plexiform neurofibroma.
FDA Grants Rezpegaldesleukin Fast Track Designation for Treatment of Children, Adults With Atopic Dermatitis
Rezpegaldesleukin is designed to balance the body’s immune system response through activation of regulatory T-cells.
