FDA Accepts BLA for Ultra Rare Enzyme Disorder
The FDA has granted priority review of velmanase alfa, an enzyme replacement, to treat patients with alpha-mannosidosis, a rare genetic disease. The FDA has assigned an action date in the first half of 2023.
FDA Accepts NDA for Rett Syndrome Drug
If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.
FDA Approves First-in-Class Therapy for Psoriasis
Developed by Bristol Myers Squibb, Sotyktu is the first approved TYK2 inhibitor. It is expected to be available later this month.
FDA Approves Rolvedon to Prevent Chemotherapy-related Infections
Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.
FDA, EMA Accept Submissions for Alopecia Therapy
The FDA is expected to make a decision on Pfizer’s ritlecitinib in the second quarter of 2023.
FDA Approves Longer-Lasting Treatment for Frown Lines
Daxxify enters the injectable botulinum toxin market as a twice-a year treatment for frown lines.
Dr. Reddy’s Launches, Cipla Receives Approval for Generic Revlimid
Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths of its generic lenalidomide capsules.
Seres Completes Rolling BLA for Microbiome Therapeutic
If approved, SER-109 to treat recurrent C. diff infections could be the first-ever FDA approved oral microbiome therapeutic.
FDA Approves Stimufend, a Biosimilar to Neulasta
Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.
FDA: Eiger’s COVID-19 Treatment not Supported by Data
The FDA would not issue an emergency use authorization for Eiger BioPharmaceuticals’ peginterferon lambda to treat patients with mild-to-moderate COVID-19.
FDA Approves Imfinzi for Metastatic Biliary Tract Cancer
A phase 3 trial showed that Imfinzi in combination with chemotherapy reduced the risk of death by 20% compared with chemotherapy alone.
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.
Hospira Recalls Another Lot of Propofol
This recall of propofol because of particulates seen in vials follows a previous one in July 2022.
Updated: Mark Cuban CostPlus Lowers Prices of 30 Drugs
The direct-to-consumer pharmacy also added 13 new products, and now carries almost 1,000 medications.
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.
AllianceRx Walgreens Pharmacy, Total Care Rx Chosen to Distribute to Hyftor
Hyftor was approved in April 2022 to treat patients with the rare disease facial angiofibroma associated with tuberous sclerosis complex.
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 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.
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