FDA Approves Oral Suspension for Gastric Ulcers
Konvomep, an oral liquid of omeprazole and sodium bicarbonate, will be available in the first quarter of 2023
FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis
With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.
FDA Approves Novel Treatment for Rare Type of Psoriasis Flare
Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.
Amneal Submits NDA for Parkinson’s Disease Therapy
This application is for a new formulation of carbidopa/levodopa extended-release capsules to treat patients with Parkinson’s disease.
FDA Approves Xenpozyme for ASMD, a Rare Genetic Disorder
Xenpozyme, the first disease-specific treatment for acid sphingomyelinase deficiency (ASMD), is expected to be available in the United States in the coming weeks at a wholesale acquisition cost of $7,142 per vial.
Hikma Launches Ryaltris for Allergic Rhinitis
Ryaltris is a fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in a nasal spray.
FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters
The approval of the updated bivalent boosters is based on data from clinical studies of the omicron variant BA.1, and animal data on the omicron BA.4 and BA.5 variant.
FDA Grants Priority Review to Weekly Hemophilia A Therapy
The target action date for the agency’s decision for efanesoctocog alfa, a factor VIII therapy, is Feb. 28, 2023.
FDA Approves First Targeted Treatment for Myeloid/Lymphoid Neoplasms
Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.
FDA Expands Imbruvica for Young Children with GVHD
Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.
Moderna Completes Application for Updated COVID-19 Booster
Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.
FDA Accepts NDA for GSK’s Myelofibrosis Drug
The FDA has assigned a Prescription Drug User Fee Act action date of June 16, 2023.
FDA Expands Use of Omnipod 5 for Younger Children
Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies.
Pfizer Submits EUA for Updated COVID-19 Booster
The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.
FDA Grants EUA for Novavax COVID-19 Vaccine for Adolescents
Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.
FDA Approves Rapid-Acting Auvelity for Major Depression
Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.
Akorn, Ani and Novadoz Launch New Generic Products
Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.
FDA Extends Mirena IUD for Eight Years of Use
Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.
FDA to Review NDA for Nonhormonal Therapy for Menopause
If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.
Sanofi Stops Development of Amcenestrant
After a failed trial in advanced breast cancer, Sanofi has stopped all studies of amcenestrant, including in early-stage breast cancer.
FDA Approves High Concentration Hadlima
Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.
FDA Approves Gene Therapy for Blood Disease
Bluebird bio has set a wholesale acquisition cost of $2.8 million for the gene therapy beti-cel, now with the brand name Zynteglo, and is offering an outcomes-based contract with an 80% risk sharing.
Counterfeit Drugs Remain a Significant Challenge
Shabbir J. Imber Safdar, executive director, Partnership for Safe Medicines, talks about efforts to address counterfeit drugs in the U.S. supply chain.
Analysis: 2022 Drug Launches Feature Record High Prices
Sean Dickson of West Health Policy Center discusses Reuters' analysis of drug launch prices.
FDA Grants Priority Review to Lynparza/Abiraterone for Metastatic Prostate Cancer
The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.
FDA Accepts Polivy sBLA for Aggressive Blood Cancer
The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.
Amneal Launches Four Generics Products
The four drugs recently launched include a generic of Clindagel, which received a competitive generic therapy designation from the FDA, for acne and Vasostrict for low blood pressure.
Quantum Leap Stops Cyclosporine Arm of I-SPY COVID Trial
Investigation into additional agents to treat patients with COVID-19 through the I-SPY COVID Trial is ongoing.
FDA Approves Xofluza to Treat and Prevent Flu in Children
Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.
FDA Approves Enhertu for Metastatic Lung Cancer
Enhertu is the first HER2 directed drug to be approved for the treatment of patients with HER2 mutated metastatic non-small cell lung cancer.
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