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Food and Drug Administration has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.The combination pill is the first and only FDA-approved triple combination.
FRIDAY, June 20, 2025 — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year. Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection. On Wednesday, the U.S.
FRIDAY, June 20, 2025 — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year.On Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection that was shown to. Wednesday, the U.S.
The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.
Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema.Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with diabetic. WEDNESDAY, Feb. 5, 2025 -- The U.S.
Food and Drug Administration has approved Andembry (garadacimab-gxii) as the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE). FRIDAY, June 20, 2025 -- The U.S. According to the Mayo.
FRIDAY, April 25, 2025 Novavaxs COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company said Wednesday.The update sent Novavaxs stock up more than 21% in early trading. It also helped ease.
Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy. MONDAY, June 30, 2025 -- The U.S. Benlysta.
Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S.
Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin. FRIDAY, Jan. 31, 2025 -- The U.S. The new pill, developed by Vertex.
A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.
August 28, 2023 -- FDA has approved several first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients six years and older and moderate to severe binge-eating.
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.
Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.
Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin.The new pill, developed by Vertex Pharmaceuticals. FRIDAY, Jan. 31, 2025 -- The U.S.
Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species transplantation.Two. TUESDAY, Feb. 4, 2025 -- The U.S.
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDAapproval of MDMA-assisted treatment for post-traumatic stress disorder.
Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.TNKase is delivered as a single five-second. THURSDAY, March 6, 2025 -- The U.S.
Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval.
Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization against invasive meningococcal disease (IMD), according to a press release from. TUESDAY, Feb. 18, 2025 -- The U.S.
Food and Drug Administration has approved Zoryve (roflumilast) topical foam 0.3 TUESDAY, May 27, 2025 -- The U.S. percent for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.Through.
This work presents a comprehensive analysis of oxygen atoms in approved drugs, aiming to streamline drug design and discovery efforts. The study examines the frequency, distribution, prevalence, and diversity of oxygen atoms in a dataset of 2049 small molecules approved by the FDA and other agencies.
Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs.DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval.
Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants. WEDNESDAY, Jan. 22, 2025 -- The U.S.
Food and Drug Administration on Friday approved FluMist nasal spray as the first influenza vaccine that can be. FRIDAY, Sept. 20, 2024 -- The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S.
Food and Drug Administration has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women (weighing 40 kg or more) and children (12 years and older. TUESDAY, March 25, 2025 -- The U.S.
TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.
Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with. THURSDAY, Feb. 6, 2025 -- The U.S.
Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology. FRIDAY, Dec. 8, 2023 -- The U.S. Casgevy, developed by Vertex.
Food and Drug Administration approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years with functional constipation. The approval was based on data from 328 participants. WEDNESDAY, June 14, 2023 -- The U.S.
Food and Drug Administration has approved the SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe aortic stenosis without symptoms. The approval is the first for TAVR. MONDAY, May 5, 2025 -- The U.S.
Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.The approval is for patients 12 years and older who remain. WEDNESDAY, April 23, 2025 -- The U.S.
Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics. So, it's welcome news that the U.S.
Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer. WEDNESDAY, May 15, 2024 -- The U.S.
TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.
Food and Drug Administration on Thursday gave full approval to the Alzheimer's drug Leqembi, clearing the way for insurance coverage of the pricey drug. “The full FDAapproval will open the floodgates for. THURSDAY, July 6, 2023 -- The U.S.
27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. FRIDAY, Sept. Food and Drug Administration.Cobenfy (xanomeline/trospium chloride) could bring patients what they've.
The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.
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