The FDA has granted Breakthrough Therapy designation to pegozafermin for the treatment of patients with nonalcoholic steatohepatitis.
All articles by Brian Park, PharmD
The FDA has approved the sNDA for Talicia® to include a new dosing regimen for the treatment of H pylori infection in adults.
Xacduro® (sulbactam for injection; durlobactam for injection) is now available for the treatment of HABP/VABP caused by A baumannii-calcoaceticus.
Moderna’s mRNA influenza vaccine, mRNA-1010, met all coprimary endpoints across all four A and B strains compared with a licensed comparator.
Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna have now been approved and authorized for emergency use.
Novartis has voluntarily recalled 1 lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to crystal formation.
Moderna’s updated COVID-19 vaccine was found to generate a strong immune response against the BA.2.86 (Pirola) variant.
Brixadi® (buprenorphine) extended-release subcutaneous injection is now available for the treatment of moderate to severe opioid use disorder.
Nonsteroidal anti-inflammatory drugs and/or acetaminophen should be used for first-line treatment of acute dental pain in pediatric patients.
Reblozyl® (luspatercept-aamt) is approved as first-line treatment of anemia in adults with very low- to intermediate-risk myelodysplastic syndromes.
The Food and Drug Administration is advising consumers not to purchase and to immediately discontinue use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to microbial contamination.
The FDA has accepted for Priority Review the NDA for cefepime-taniborbactam for the treatment of adults with complicated UTI, including pyelonephritis.
The FDA has extended the review period of the BLA for the chikungunya virus vaccine candidate, VLA1553.
The FDA has accepted the sNDA for isavuconazonium sulfate for the treatment of invasive aspergillosis or invasive mucormycosis in pediatric patients.
The chikungunya virus vaccine candidate, CHIKV VLP was found to be highly immunogenic in adults and adolescents.
OCS-01 is a novel, high concentration (15 mg/mL), topical formulation of dexamethasone.
Rezzayo is supplied as a solid (cake or powder) in a single-dose vial containing 200mg of rezafungin.
V116 is an investigational 21-valent pneumococcal conjugate vaccine.
Ycanth is expected to be available by September 2023.
Cyfendus is made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of B. anthracis.
Both Hikma Pharmaceuticals and Par Pharmaceuticals will be supplying the product.
Removing the prescription requirement improves access to an effective contraceptive method for women of all ages.
The 100mcg per 2mL presentation is offered in a manufacturer-prepared prefilled syringe.
The full data set from the FORMULA-OLS study will be submitted as part of the revised NDA.
Arexvy is expected to be available for the 2023-2024 RSV season.
CAL02 is a first-in-class non-biological, broad-spectrum, bacterial virulence neutralizer.
If approved by the third quarter of 2023, the Company expects to make nirsevimab available for the 2023 to 2024 RSV season.
Vowst is supplied in a bottle containing 12 capsules.
Brixadi is supplied as prefilled single-dose syringes in weekly (8mg, 16mg, 24mg, 32mg) and monthly (64mg, 96mg, 128mg) doses.