The agency may put in place a personalized risk assessment to replace the current prohibition on men who have had sex with men in the previous three months.
The therapy will cost nearly $200,000. But it’s the first treatment in 100 years to alter the course of the disease, which usually begins in adolescence.
On Tuesday, the state’s voters overwhelmingly supported letting a two-year-old law take effect. The company’s lawsuit is viewed by anti-smoking advocates as a tactic that could keep menthol cigarettes on the market longer.
The agency has weighed years of study that showed the treatment given accelerated approval 11 years ago was not effective.
The agency cited Teva’s continuing supply problems as well as those of other drug makers struggling to fill the gap.
Over-the-counter hearing aids are coming at long last. But lower prices and greater accessibility may take time to materialize.
While use among youths has fallen since the peaks of 2018-19, resumption of in-school classes this year shows students still have access to flavored, disposable vapes.
The list price of the therapy, Relyvrio, is much higher than an economic research group recommends, but the company says most patients will pay very little themselves.
Salmon is in; sugary yogurt is out.
The drug is safe, and one trial found it may extend survival and slow paralysis in functions like muscle control and speaking. A larger trial will be completed in 2024.