All News |

Konvomep, an oral liquid of omeprazole and sodium bicarbonate, will be available in the first quarter of 2023

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.

Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.

This application is for a new formulation of carbidopa/levodopa extended-release capsules to treat patients with Parkinson’s disease.

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.

Ryaltris is a fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in a nasal spray.

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.

The target action date for the agency’s decision for efanesoctocog alfa, a factor VIII therapy, is Feb. 28, 2023.

Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.

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.

Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.

The FDA has assigned a Prescription Drug User Fee Act action date of June 16, 2023.

Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies.

The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.

Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.

Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.

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.

After a failed trial in advanced breast cancer, Sanofi has stopped all studies of amcenestrant, including in early-stage breast cancer.

Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.

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.

Shabbir J. Imber Safdar, executive director, Partnership for Safe Medicines, talks about efforts to address counterfeit drugs in the U.S. supply chain.

Sean Dickson of West Health Policy Center discusses Reuters' analysis of drug launch prices.

The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.

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.

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.

Investigation into additional agents to treat patients with COVID-19 through the I-SPY COVID Trial is ongoing.

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.

Enhertu is the first HER2 directed drug to be approved for the treatment of patients with HER2 mutated metastatic non-small cell lung cancer.