The approval was based on data from the KEYNOTE-224 study, a single-arm trial in patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib; had measurable disease; and Child-Pugh class A liver impairment.
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.
HHS study shows Medicare pays 80 percent more than other countries for certain prescription drugs
Newly approved treatment options for axillary hyperhidrosis give more opportunities for clinicians to provide personalized treatment for patients.
The expanded approval was supposed by safety and efficacy data from the Phase 3 ACCESS IUS trial (N=1751) in women receiving Liletta. In the trial, Liletta demonstrated >99% efficacy in preventing pregnancy for up to 5 years in a broad patient population.
Eravacycline was well-tolerated in clinical trials and achieved high cure rates in patients with Gram-negative pathogens (including resistant strains).
Cassipa combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist.
Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals.
A Phase 1 study in healthy volunteers showed a favorable safety profile with no serious adverse events.
The FDA has set a Prescription Drug User Fee Act target date of April 1, 2019.
