Steve Duffy

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Most Recent Articles by Steve Duffy

Opsumit sNDA Submitted for Chronic Thromboembolic Pulmonary Hypertension

Opsumit sNDA Submitted for Chronic Thromboembolic Pulmonary Hypertension

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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.

FDA Announces New Initiative Aimed at Stopping Youth Use of E-Cigarettes

FDA Announces New Initiative Aimed at Stopping Youth Use of E-Cigarettes

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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 Granted Priority Review for NSCLC With EGFR-Activating Mutations

Dacomitinib Granted Priority Review for NSCLC With EGFR-Activating Mutations

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Dacomitinib is a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.

Novel Cystic Fibrosis Treatment Granted Fast Track Status

Novel Cystic Fibrosis Treatment Granted Fast Track Status

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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 Sinus Implant Launched to Treat Recurrent Nasal Polyps

Sinuva Sinus Implant Launched to Treat Recurrent Nasal Polyps

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Sinuva can be implanted during a routine physician visit under local or topical anesthesia.

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