SPOTLIGHT -
FDA Approves New Indication for Gammagard Liquid
Gammagard is an intravenous immunoglobulin therapy now approved to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.
Celltrion USA Seeks Approval for Actemra Biosimilar
Celltrion’s application is based on data from a phase 3 trial of patients with rheumatoid arthritis comparing its biosimilar with Actemra.
Product Mix Up Leads to Recall of Narcolepsy Drug Zenzedi
The antihistamine drug carbinoxamine was found in one bottle Zenzedi, which is used to treat narcolepsy and ADHD.
FDA Approves Dupixent in Young Children with Eosinophilic Esophagitis
Eosinophilic esophagitis is progressive disease driven in part by type 2 inflammation. Dupixent is the first treatment for children as young as 1 year old.
Asthma Rescue Medication Airsupra is Now Available
Airsupra is an anti-inflammatory rescue medication that can treat the symptoms of asthma while helping to prevent an attack.
FDA Grants Full Approval of Balversa in Bladder Cancer
Balversa targets FGFR3 genetic alterations and is approved as a second-line treatment for in adult patients with metastatic urothelial carcinoma.
FDA Adds Boxed Warning to Prolia in Patients with Kidney Disease
Regulators are warning about the increased risk of very low blood calcium levels in patients with advanced chronic kidney disease.
FDA Approves HyQvia as Maintenance Therapy for Rare Neuromuscular Disorder
HyQvia is now available a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy, which can lead to weakness and loss of feeling in the arms and legs.
FDA Approves Second Indication for the Gene Therapy Casgevy
With a cost of $2.2 million, Casgevy is a CRISPR/Cas9 gene-edited cell therapy that is now also approved to treat beta thalassemia. It was approved to treat sickle cell disease in December 2023.
Gene Therapy for Bladder Cancer Now Fully Available
Adstiladrin delivers a gene that encodes for the interferon alpha-2b protein, and it provides an option for those at high risk of recurrence and metastatic bladder cancer.
FDA Finds No Link Between GLP-1 Drugs and Thoughts of Suicide
Regulators will continue to evaluate a possible link by reviewing meta-analysis of clinical trials across all GLP-1 products and analyzing postmarketing data in the Sentinel System.
Harrow Launches Vevye for Dry Eye Disease
Vevye is a water- and preservative-free solution of cyclosporine, which allows for improved bioavailability.
Court Approves Rite Aid’s Sale of Elixir PBM to MedImpact
The transaction is valued at about $575 million. The sale is part of Rite Aid’s restructuring plan after filing for bankruptcy in October 2023.
FDA Assigns Review Date for Full Approval of Tivdak for Cervical Cancer
Tivdak was granted accelerated approval in September 2021 to treat patients with recurrent or metastatic cervical cancer. The goal date for full approval is May 9, 2024.
FDA Issues CRL for Zolbetuximab Biologics License Application
The FDA cited issues with a third-party manufacturing company. Zolbetuximab is being reviewed to treat patients with stomach cancer.
FDA Approves Gel for Skin Infection Caused by Poxvirus
Zelsuvmi, a first-in-class topical treatment approved for patients with molluscum contagiosum, will be available in the second half of 2024.
Drug Channels Acquired by HMP Global
Adam Fein, founder of Drug Channels, said the acquisition will allow the company to upgrade its technology, grow the company and provide live and in-person events.
FDA Accepts Accord’s BLA for Stelara Biosimilar
If approved, Accord’s biosimilar would treat several autoimmune conditions and would be launched no later than May 15, 2025
Coherus Launches Loqtorzi for Nasopharyngeal Carcinoma
Loqtorzi has a wholesale acquisition cost of $8,892.03 per single-use vial.
Glass in Vials Leads to Recall of Several Hospira Products
The presence of glass can lead to serious adverse events, including inflammation of a vein and blockage of blood vessels or life-threatening blood clots.
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FDA Approves Rare Disease Drug Wainua
Wainua is approved to treat patients with hereditary transthyretin-mediated amyloid polyneuropathy and can be self-administered via an auto-injector.
FDA and Novo Nordisk Warn about Counterfeit Ozempic
The FDA has seized thousands of units of counterfeit Ozempic 1 mg.
FDA Grants Full Approval to Tarpeyo for Rare Kidney Disease
This is the first treatment for patients with primary immunoglobulin A nephropathy to be granted full approval.
Merck Receives Complete Response Letter for Cough Drug Gefapixant
This is the second complete response letter for gefapixant, and FDA officials said the application did not provide evidence of effectiveness.
Harm Reduction Launches Naloxone Nasal Spray
Nonprescription RiVive was approved in July 2023 to reverse opioid overdose. Harm Reduction is donating 200 doses to Remedy Alliance for distribution.