FDA Grants Priority Review for Novel C. Difficile Therapeutic
If approved, SER-109 would be the first oral microbiome therapeutic available. The Prescription Drug User Fee Act action date is April 26, 2023.
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.
FDA Clears Novel Liver Cancer Combo Treatment
Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.
FDA Accepts Supplemental Application for Camzyos
The FDA has assigned a PDUFA goal date of June 16, 2023, for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy.
FDA Grants Six Months Pediatric Exclusivity for Eylea
Eylea is being reviewed as a treatment for retinopathy in premature infants.
Novavax COVID-19 Vaccine Booster Gets FDA EUA
Novavax’ protein-based vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
FDA Extends Review Time for Biogen’s ALS Therapy
If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The updated PDUFA date is April 25, 2023.
FDA Accepts BLA for Hemophilia A Gene Therapy
If approved, valoctocogene roxaparvovec would be the first gene therapy in the U.S. for the treatment of severe hemophilia A. A PDUFA action date has been set for March 31, 2023.
FDA Authorizes Updated COVID-19 Boosters for Younger Children
The bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 along with a component of omicron BA.1.
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
The FDA has assigned a target action date of Feb. 11, 2023.
Nonprofit Company Begins Application Process for OTC Naloxone
The submission is expected to be complete by the end of the year, and if approved, could be available in early 2024.
FDA Issues CRL for Parkinson’s Therapy
The FDA is asking for additional analysis related to the infusion device used with SPN-830, which contains apomorphine to treat patients with Parkinson’s disease.
FDA Approves Heart Failure Therapy that Provides an Alternative to Hospital Treatment
Furoscix can be administered at home with the use of the On-Body Infusor, which delivers furosemide over five hours. It will be launched in the first quarter of 2023.
FDA Uses Real-World Data to Approve Boostrix for Prevention of Infection in Infants
Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.
FDA Approves Label Expansion for Oxlumo
This approval for Oxlumo adds lowering plasma oxalate levels for patients with primary hyperoxaluria type 1, a rare and life-threatening metabolic disease.
Eiger Will Not Submit EUA For COVID-19 Treatment
The FDA had indicated that it would not issue an emergency use authorization without additional data for peginterferon lambda to treat patients with mild-to-moderate COVID-19.
FDA Accepts BLA for Takhzyro in Young Children with HAE
The FDA is expected to make a decision on approval in this patient population in the first half of 2023.
OIG: One-third of Accelerated Approvals have Delayed Confirmatory Trials
Medicare and Medicaid spent more than $18 billion on drugs without verified clinical benefit.
U.S. to Buy up to $10.7 Million of Monkeypox Treatment
SIGA indicated that $5.1 million of oral Tpoxx is targeted for delivery in 2022.
FDA Approves New Administration Method for Trogarzo in HIV
Trogarzo was approved with a new method of administration designed to make maintenance dosing easier for patients and healthcare providers.
BioMarin Resubmits BLA for Hemophilia A Gene Therapy
If approved, valoctocogene roxaparvovec would be the first commercially-available gene therapy in the United States for the treatment of severe hemophilia A.
FDA Approves Therapy for Bile Duct Cancer
Taiho’s Lytgobi is approved to treat advanced or metastatic advanced bile duct cancer in patients with FGFR2 gene fusions.
FDA Approves Amylyx’s ALS Therapy
Now with the brand name Relyvrio, the new therapy should be available within four to six weeks. It will have a wholesale acquisition cost of $158,000 per year.
FDA Approves Duxipent for Rare Skin Disorder
Dupixent is the first treatment approved to treat prurigo nodularis, a chronic skin disorder characterized by the presence of hard, itchy nodules.
FDA Approves Fourth Avastin Biosimilar
Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.
FDA Accepts NDA for Therapy for Rare Immunodeficiency Disease
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 29, 2023, for a decision on leniolisib as a treatment for APDS, a rare primary immunodeficiency.
FDA Approves Omlonti for Glaucoma
Omlonti is approved to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension
HHS ups COVID-19 Med Bebtelovimab Availability
Bebtelovimab is available under an emergency use authorization, and the HHS is making doses available to those who are uninsured and underinsured.
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
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