FDA Approves Ruzurgi for Children With Rare Autoimmune Disorder
Ruzurgi previously approved for treatment in adults with Lambert-Eaton myasthenic syndrome.
Drug Approvals
Osphena Approved for Moderate to Severe Vaginal Dryness Due to Menopause
The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness.
Tosymra Approved for the Acute Treatment of Migraine
Tosymra is an intranasal spray containing sumatriptan 10mg, a selective 5-HT1B/1D receptor agonist.
Keytruda Gets FDA Approval for Hepatocellular Carcinoma
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.
Oral Therapy for Suicidal Bipolar Depression Gets Breakthrough Designation
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.
Trump Administration Announces Plan to Cut Drug Prices
HHS study shows Medicare pays 80 percent more than other countries for certain prescription drugs
Solutions for Hyperhidrosis: Newly Approved Treatments and Research Update
Newly approved treatment options for axillary hyperhidrosis give more opportunities for clinicians to provide personalized treatment for patients.
Liletta Now Approved for Pregnancy Prevention for Up to 5 Years
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.
Xerava Approved for the Treatment of Complicated Intra-Abdominal Infections
Eravacycline was well-tolerated in clinical trials and achieved high cure rates in patients with Gram-negative pathogens (including resistant strains).
Cassipa Approved as Maintenance Treatment for Opioid Dependence
Cassipa combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist.
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