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 ...
WASHINGTON, March 6 (Xinhua) -- TheUnited StatesFood and Drug Administration (FDA) approved on Tuesday a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other ...
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...
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...
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. ...
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. ...
NANJING, June 7 (Xinhua) -- China Food and Drug Administration (FDA) has approved the sale of a new drug for the treatment of HIV-1 infection, the maker of the drug said. Aikening, or albuvirtide for injection (ABT), can be used with other antiretroviral drugs to treat infected patie...