FDA Grants Priority Review for Tibsovo sNDA for Myelodysplastic Syndromes
Tibsovo is currently approved in the United States as a monotherapy to treat adults with IDH1-mutant relapsed or refractory acute myeloid leukemia.
FDA Sets Review Date for Combination Antibiotic for Complicated UTIs
The FDA has granted priority review for cefepime-taniborbactam to treat patients with complicated urinary tract infections and set an action date of Feb. 22, 2024.
FDA Grants Accelerated Approval to Elrexfio for Multiple Myeloma
Elrexfio is a bispecific antibody to treat relapsed or refractory multiple myeloma. It will be available within the next few weeks and have a monthly list price of $41,500.
FDA Approves Long-Acting Botulinum Toxin for Cervical Dystonia
Daxxify is a long-acting botulinum toxin that will launch in 2024. It previously received FDA approval to treat frown lines.
FDA Approves Combination Tablet for Metastatic Prostate Cancer
The combination of niraparib and abiraterone in a single tablet — now with the name Akeega — will be available in mid-September and have a list price of $18,750 for a 30-day supply.
What We’re Reading: Drug Prices May Lead to ACA Premium Increases; Dealing with Problem Doctors; Autism, Obesity and Other Co-Occurring Conditions
FDA Approves Talvey to Treat Blood Cancer
Talvey is a first-in-class bispecific antibody to treat adult patients with relapsed or refractory multiple myeloma. It will available in a few weeks and have a price of $45,000 per month.
FDA Issues Complete Response for Avasopasem for Severe Oral Mucositis
Avasopasem was under review to treat radiotherapy-induced severe oral mucositis in patients with head and neck cancer. The FDA has indicted that an additional trial would be needed to show safety and effectiveness of avasopasem.
FDA Approves Izervay to Treat Geographic Atrophy
Izervay, which is expected to be available within the two to four weeks, will have a list price of $2,100 per vial.
FDA Approves Oral Treatment for Postpartum Depression
Zurzuvae is a rapid-acting neuroactive steroid that is expected to be available in the fourth quarter of 2023.
FDA Approves Lonsurf Combination for Metastatic Colorectal Cancer
Trial results showed that the combination of Lonsurf and bevacizumab provided improvements in overall survival.
What We’re Reading: Research Data Manipulation; Maternal Deaths from Lack of Abortion Care
FDA Approves Jemperli as Frontline Treatment for Advanced Endometrial Cancer
Jemperli is the first immuno-oncology treatment approved in the frontline setting for patients with advanced or recurrent endometrial cancer.
FDA Rejects BLA for Therapy to Treat Rare Skin Cancer
The FDA is requiring Citius Pharmaceuticals to do enhanced product testing for Lymphir (formerly I/Ontak) to treat patients with cutaneous T-cell lymphoma.
FDA Approves Second Over the Counter Naloxone Nasal Spray
Harm Reduction Therapeutics will supply at least 200,000 free doses of RiVive to communities that need it most.
Pfizer Tornado Plant Damage Not Affecting Penicillin Supply
The supply of fentanyl, epinephrine injection, and heparin, however, have been impacted by the July 19 tornado at Pfizer's North Carolina facility.
What We’re Reading: Medicaid Enrollment, Jailing People with Mental Illness and Ensuring Mental Health Parity
FDA Approves Xdemvy for Eye Infection Caused by Mites
Xdemvy is the first treatment that directly targets the mites involved in the Demodex blepharitis. It is expected to be available by the end of August 2023 and will have a list price of $1,850 per prescription.
FDA Accepts sNDA for Ofev in Children with Rare Lung Disease
If approved, Ofev would be the first approved treatment for children and adolescents with fibrosing interstitial lung disease. A decision is expected in the fourth quarter of this year.
FDA Approves First Drug for Skin Infection from Pox Virus
Ycanth, a topical treatment for molluscum contagiosum, will be available in September. Pricing information has not yet been released.
FDA Approves Postexposure Anthrax Vaccine
Emergent BioSolutions has been providing the Cyfendus vaccine to the U.S. Department of Health and Human Services since 2019, under a pre-emergency use authorization status.
FDA Approves Novel Therapy for Newly Diagnosed AML
Vanflyta is the first FLT3 inhibitor approved to treat patients with newly diagnosed acute myeloid leukemia across three phases of treatment. It has a list price of $199,290 annually.
FDA Clears First Monoclonal Antibody for RSV in Infants
Beyfortus will be available ahead of the upcoming 2023-2024 RSV season. A price has not yet been set.
FDA Decision on Donanemab for Alzheimer’s Expected by End of Year
Donanemab slowed cognitive decline by about 35% for patients at the earliest stages of Alzheimer’s disease.
FDA Approves First Nonprescription Oral Contraceptive
Opill will be available in stores and online in the first quarter of 2024.
Takeda Pulls Application for Dengue Vaccine
Takeda indicated that it could not address issues related to aspects of data collection within the current BLA review cycle.
FDA Approves Leqvio for Earlier Use in Heart Disease
The label for Leqvio has also been updated to remove four adverse events based on recent safety data.
CMS Expands Leqembi Coverage After FDA’s Full Approval
Medicare will cover Alzheimer’s drugs with full approval, including Leqembi — if the physician and patient participate in a real-world registry trial to gather additional data.
FDA Sets Action Date for Zolbetuximab for Stomach Cancers
Zolbetuximab is a first-in-class therapy for advanced gastric and gastroesophageal cancers. The target action date is Jan. 12, 2024.
Prime Therapeutics Names Mostafa Kamal President and CEO
The Magellan Rx Management CEO is replacing Ken Paulus, who has held the top job at Prime since May 2019.
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