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...
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...
In June, FDA approved the first nonprescription nasal antihistamine to expand treatment options for patients age six and older; younger children still have to obtain Bayer Healthcare’s Astepro (0.15% azelastine hydrochloride nasal spray) on a prescription basis. Important news on the approvals ...
One hurdle health authorities have worked to plan out is how the safety of nirsevimab will be monitored between the FDA and CDC. Reports of adverse events in babies after getting the injections will need to be routed through a separate system run by the FDA for drugs, which works differen...
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is res...
After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial's participants achieved HIV RNA suppression, FDA said. A total of 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion. The most common adverse reactions to Trogarzo were diarrhea, dizzine...
Ad 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. ...
The US Food and Drug Administration (FDA) has approvedefgartigimod(Vyvgart, argenx), a first-in-class,targeted therapyfor adults with generalizedmyasthenia gravis(gMG) who test positive for the antiacetylcholine receptor (AChR) antibody.
Current FDA-Related Drug Information - New Drugs Approved by the FDA; New Dosage Forms and Indications Approved by the FDA; Agents Pending FDA Approval; New Drug Applications Filed by Manufacturer; Supplemental Applications Filed by Manufacturer; Significant Labeling Changes or 鈥淒ear Health Care ...
A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...