Our analyses follow the same protocol as those for newly approved drugs in 2020–2022 (Kayki-Mutlu and Michel2021; Kayki-Mutlu et al.2022,2023) with one exception. Unlike in previous years, we have included cellular and gene therapies approved by the FDA (U.S. Food and Drug Administration...
After 2022 produced just 37 new drug approvals—the fewest by the FDA since 2016—the United States regulatorsigned offon a bumper crop of 55 new drugs in 2023. The list was the second longest in FDA history, coming up just shy of the single-year record of 59 approvals, ...
new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 Chris De Savi另外制作了一个图。
By recent standards, the first quarter of 2024 has been relatively slow in terms of novel drug approvals. Only 10 new drugs were granted authorization in the first three months of the year (Tablel). This compares to 13 in the first quarter of 2023 -a figure that was equalled or best...
FDA Approved: June 22, 2023 Company: Sarepta Therapeutics Elevidys is an adeno-associated virus vector-based gene therapy and the first gene therapy for DMD. Elevidys is indicated for the treatment of DMD in individuals at least 4 years of age who are either ambulatory and have a confirmed...
The following drugs are FDA approved for theacute treatmentof migrainewith or without aurain adults. Drug NameFDA ApprovalCompanyDrug ClassDosage FormAdministration RizaFilm (rizatriptan)April 14, 2023IntelGenx Corp.serotonin (5-HT)1B/1Dreceptor agonist (triptan)oral film ...
Despite the drugs effectiveness, it does have a serious side effect called a cytokine release syndrome, the FDA said. That's when theimmune systemgoes into overdrive, triggering symptoms like a rash, a rapid heartbeat and low blood pressure. ...
Introduction Biologic drugs are used to treat various illnesses like autoimmune diseases, cancers, hormonal irregularities, anemia, etc., and to prevent va... VA Shinde,R Patil,PYS Bhandari - 《Cureus》 被引量: 0发表: 2023年 Development of Glatopa? (Glatiramer Acetate): The First FDA-Approv...
New Drugs Approved by the FDA New Dosage Forms and Indications Agents Pending FDA Approval Major Labeling Changesdoi:10.1177/001857879903401010This monthly feature is designed to help readers keep current on new drugs, new indications and dosage forms, and safety-related changes in labeling or use. ...
All three drugs contain a new active ingredient, alogliptin, either alone or in combination with other, previously approved medications. The newly approved drugs include Nesina (alogliptin), Kazano (alogliptin plus metformin) and Oseni (alogliptin plus pioglitazone), the FDA said in a news release....