Most Recent Articles by Steve Duffy
The sNDA is accompanied by results from the MERIT-1 trial, a Phase 2 randomized, placebo-controlled, double-blind study which assessed the efficacy, safety and tolerability of macitentan 10mg in 80 patients with inoperable CTEPH.
In a wide ranging statement, the FDA commissioner Scott Gottlieb, MD, specifically targets novel nicotine-delivery products as being problematic since many of these devices resemble USB flash drives, have high nicotine levels and have emissions that are hard to see.
Dacomitinib is a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
Proteostasis Therapeutics is developing the combination treatment which includes a novel transmembrane conductance regulator (CFTR) amplifier (PTI-428), a third generation corrector (PTI-801) and a potentiator (PTI-808).
Sinuva can be implanted during a routine physician visit under local or topical anesthesia.