The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SEP-363856 (Sunovion), an investigational treatment for schizophrenia. SEP-363856 is believed to work by activating trace amine-associated receptor 1 (TAAR1) in addition to 5-HT1A receptors; unlike other antipsychotics, this novel agent does not bind to D2 or 5-HT2A receptors. The Breakthrough Therapy designation was…
Truvada is approved in combination with safer sex practices for HIV-1 PrEP to reduce the risk of sexually acquired HIV-1.
Sorilux Foam contains calcipotriene, a synthetic vitamin D3 analog that has a similar receptor binding affinity as natural vitamin D3.
The supplemental New Drug Application (sNDA) for Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets; Gilead), for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in those who are HIV-negative and at risk for HIV, has been submitted to the Food and Drug Administration (FDA) for review.
The Food and Drug Administration (FDA) has approved Avaclyr (acyclovir ophthalmic ointment; Fera Pharmaceuticals) 3% for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.
Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38% has been made available by Bausch + Lomb for the treatment of postoperative inflammation and pain following ocular surgery.
Vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, was found to be superior to adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC), according to results from a phase 3b head-to-head trial.
The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.
The Food and Drug Administration has accepted for review the New Drug Application for a novel oral fumarate candidate, diroximel fumarate (Alkermes and Biogen), for the treatment of relapsing forms of multiple sclerosis.
According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).
