FDA
The newly approved drug, Lybalvi, is a once-daily oral antipsychotic drug that is both a maintenance monotherapy or for the acute treatment of manic or mixed episodes.
FEATURED STORIES
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels.
The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
The approval of Jakafi marks the first approved treatment for this indication in the United States.
The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
Sorilux was approved for the treatment of patients age 12 and up.
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.
NAYZILAM was approved to treat frequent seizure cluster episodes in epilepsy patients.
Pfizer’s Fragmin was approved to reduce the recurrence of VTE in patients one month of age or older.