Final results from a phase 3 study found that Copiktra was associated with a higher risk of serious side effects, dose modifications, and deaths compared with Kesimpta.
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The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated people at high risk for progression to severe illness from COVID-19.
Zelnorm is used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation.
Palovarotene is being reviewed as a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Dec. 29, 2022.
The FDA is accepting comments on the proposed rule through Oct. 26, 2022.
Sanofi has lowered the out-of-pocket cost for those without insurance of its insulins to $35 for a 30-day supply through the company’s savings program.
Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.
Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.
If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.
The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.
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Diacomit was approved in 2018 for seizures associated with Dravet syndrome, a rare pediatric disorder.
Labels now warn that buprenorphine products that dissolve in the mouth can cause dental problems. Buprenorphine is used to treat opioid use disorder and pain.
Breyanzi is now available as a second-line treatment for this aggressive blood cancer.
Generics of Viibryd, Tranxane and Timoptic have recently been approved and launched.
Byetta is used to control blood sugar in patients with diabetes. A new warning includes the risk of gallstones and gallbladder inflammation.
Benefits leaders surveyed in PSG’s Trends in Drug Benefit Design Report say the importance of the member experience has increased since the start of the pandemic.
Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.
The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.
Increased demand for certain medications used to treat hospitalized patients with COVID-19 had a significant impact on medication supply last year.
The company will take no profit, which is part of the company’s bankruptcy filing and settlement with states.
The Cardiovascular and Renal Drugs Advisory Committee meets Nov. 16, 2022, to discuss Xphozah for patients with kidney disease.
If approved, Qulipta would be the first oral calcitonin gene-related peptide receptor antagonist with a broad preventive treatment of both chronic and episodic migraine.
Xipere became commercially available in March 2022. It is the first therapy for patients with macular edema that provides a targeted delivery to the retina.
A study in the journal Blood has found that the cost-effectiveness of the Polivy treatment regimen used to treat patients with diffuse large B-cell lymphoma would decrease if the five-year progression-free survival decreased.
Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.
Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.
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