Herceptin Hylecta Approved for the Treatment of HER2-Overexpressing Breast Cancer
The Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for the treatment of HER2-overexpressing breast cancer.
All articles by Diana Ernst, RPh
Tremfya One-Press Patient-Controlled Injector Approved for Patients With Moderate-to-Severe Plaque Psoriasis
The FDA has approved Tremfya (guselkumab; Janssen) One-Press, a single-dose patient-controlled injector for the treatment of moderate-to-severe plaque psoriasis in adults.
Liquid Levothyroxine Formulation Now Available to Treat Hypothyroidism
Tirosint-SOL (levothyroxine sodium oral solution) has been made available by IBSA Pharma for the treatment of hypothyroidism and pituitary thyrotropin suppression.
Gloperba Approved for the Prophylaxis of Gout Flares
The Food and Drug Administration has approved Gloperba (colchicine; ROMEG Therapeutics) Oral Solution for the prophylaxis of gout flares in adults. It is the first liquid formulation of colchicine to be approved by the FDA for this indication.
Baricitinib Beneficial in Two Phase 3 Atopic Dermatitis Trials
Lilly and Incyte announced positive top-line results from two Phase 3 clinical trials evaluating baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis. Results from the BREEZE-AD1 and BREEZE-AD2 placebo-controlled trials showed that treatment with baricitinib monotherapy led to a statistically significant proportion of patients achieving Investigator’s Global Assessment for Atopic Dermatitis score of clear…
DocuSol Kids Available OTC for Children With General Constipation
DocuSol Kids has been made available by Alliance Labs for the over-the-counter (OTC) treatment of general constipation in children 2–12 years of age. Each DocuSol Kids mini-enema (5mL) contains a delivered dose of docusate sodium 100mg in a polyethylene glycol base. The soft flexible tip allows for easy rectal usage under adult supervision. According to…
FDA Rejects Opioid System Modulator NDA for Depression Treatment
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Alkermes regarding the New Drug Application (NDA) for ALKS 5461, an investigational adjunctive treatment for major depressive disorder (MDD). ALKS 5461 is an oral medication that acts as an opioid system modulator and is being proposed for once-daily administration. It consists…
AGS: Beers Criteria for Potentially Inappropriate Med Use in Older Adults Updated
Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.
Does DPP-4 Inhibitor Use Increase the Risk of Developing IBD?
To investigate the association between this diabetes drug class and IBD risk, the study authors searched various databases for controlled clinical trials and observational studies involving DPP-4 inhibitors where IBD events were reported.
Investigational Treatment for Multiple System Atrophy Gets Orphan Drug Status
Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease.
