Lundbeck gets FDA nod for migraine prevention drug Vyepti
Claimed to be the first FDA-approved intravenous (IV) treatment for migraine prevention, the Vyepti will be available from April and the recommended dose is 100mg for every three
Gilead Sciences and the Pan American Health Organization (PAHO) have signed an agreement to expedite access to the company’s twice-yearly lenacapavir injection for human immunodeficiency virus (HIV) prevention as pre-exposure prophylaxis (PrEP) across Latin America and the Caribbean.
“These designations for FORMA’s lead clinical asset underscore the FDA’s continued recognition of the needs of patients with SCD,” said Frank Lee, chief executive officer of FORMA Therapeutics.
The FDA is expected to make a decision on approval by June 19, 2020. “In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared
The breakthrough therapy status enables Padcev plus Keytruda combination to treat patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in
The submitted applications are based on pharmacokinetic modeling and simulation data presented at the 2018 ASCO Annual Meeting. These data supported the European Commission approval of 400 mg