Fda
FDA approves targeted interleukin-13 inhibitor for moderate-to-severe atopic dermatitis
Eli Lilly and Company announced it received FDA approval for Ebglyss for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies, according to a company press release.
FDA approves first twice-a-year, subcutaneous injection for multiple sclerosis
Genentech announced it received FDA approval for Ocrevus Zunovo to treat patients with relapsing and primary progressive multiple sclerosis, according to a company press release.
FDA approves first subcutaneous anti-PD-L1 cancer immunotherapy
The FDA approved atezolizumab and hyaluronidase-tqjs for subcutaneous injection.
FDA warns of potential liver injury with Veozah for menopausal hot flashes
The FDA issued a warning that use of fezolinetant, a nonhormonal medication indicated for treating menopausal hot flashes, can cause rare but serious liver injury, according to an agency press release.
FDA grants orphan drug designation to calcium channel blocker for systemic sclerosis
The FDA has granted orphan drug designation to AISA-021, a fourth-generation calcium channel blocker, for the treatment of systemic sclerosis, according to a press release from Aisa Pharma.
FDA clears OCTA on robotic Maestro2 color fundus camera system
The FDA granted 510(k) clearance for OCT angiography on the robotic Maestro2 OCT color fundus camera system, according to a press release from Topcon Healthcare.
Tremfya nabs FDA approval for active ulcerative colitis, chasing competitor Skyrizi
The FDA has approved Johnson & Johnson’s Tremfya, a dual acting interleukin-23 inhibitor, for the treatment of patients with moderately to severely active ulcerative colitis, according to a company release.
FDA clears transcutaneous electrical nerve stimulation device for chronic pain
The FDA has granted clearance to a Colorado-based medical technology company’s transcutaneous electrical nerve stimulation device for those suffering from chronic pain, according to a press release.
FDA grants 510(k) clearance to under-mattress device that assists in OSA diagnosis
The FDA has granted 510(k) clearance to the Sleep Rx Mat, a clinically validated mat that fits under any mattress and assists in the diagnosis of sleep apnea in adults with suspected sleep breathing disorders, according to a press release.
Akebia readies launch of anemia drug Vafseo; planning talks with FDA on pre-dialysis use
As Akebia Therapeutics announced plans to launch its anemia drug Vafseo to the dialysis community, company officials said they intend to work with the FDA for more testing of the drug for the pre-dialysis market.