Tag: Drug Approvals
FDA Grants Full Approval to Paxlovid to Treat COVID-19
Paxlovid has been taken by seniors and others at high risk for severe COVID-19 under an emergency use approval
FDA Approves New Nasal Spray to Reverse Overdoses
To be sold as Opvee, the spray contains the medication nalmefene hydrochloride and will be available with a prescription
Epkinly Granted Accelerated FDA Approval for Lymphoma
Approved for use in relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
FDA Approves First Pill to Treat Moderate-to-Severe Crohn Disease
In clinical trials, more patients taking Rinvoq achieved remission and reduced intestinal inflammation compared with patients given a placebo
FDA Approves First Nonhormonal Drug to Ease Menopause Hot Flashes
Veozah targets the neurokinin 3 receptor, which is linked to the regulation of body temperature
FDA Approves First Drug Meant to Ease Alzheimer Disease-Linked Agitation
Patients who received 2 or 3 mg of Rexulti had significant improvements in agitation scores compared with patients taking a placebo
FDA Approves Lumryz for Narcolepsy
Approval is for treatment of excessive daytime sleepiness with once-at-bedtime dosing
FDA Approves First RSV Vaccine
Arexvy was ~82 percent effective in preventing RSV-induced lower respiratory tract infections in adults 60 years of age and older
FDA Approves First Pill for Fecal Transplant Therapy
Vowst is approved to prevent recurrence of C. difficile; pill contains live gut bacteria from stool samples donated by healthy people
FDA Approves Drug for Rare Form of ALS
Agency approved the drug based on evidence of a reduction in plasma neurofilament light; no evidence the drug slowed the disease
