sNDA
Karyopharm Plans August FDA Filing for Selinexor Combination
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company focused on cancer therapies, plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration in August 2026 for selinexor in combination with ruxolitinib as a treatment for myelofibrosis. The company said it will seek accelerated approval following discussions with the FDA.…
What Is Off-Label Drug Use? The Practice Every Biotech Investor Should Understand
When the FDA approves a drug, it approves it for a specific indication — a defined patient population with a defined disease or condition. But once a drug is on the market, physicians are legally permitted to prescribe it for any use they believe is in their patient’s best interest, including uses not mentioned on…
