Expanded indication for MS treatment granted
Interferon beta-1b (Betaseron, Berlex) can now be prescribed to patients with multiple sclerosis who have experienced a first clinical episode and have MRI features consistent with MS. The new approval was based on findings from BENEFIT, a study of patients experiencing their first clinical demyelinating event. Results showed the drug delayed time to a second event by one year compared with placebo. Betaseron is also indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
