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March 19, 2022

FDA Approves New Immunotherapy Combo for Melanoma FDA Approves New Immunotherapy Combo for Melanoma

The FDA tonight approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older, according to […]
March 16, 2022

FDA Approves Generic Symbicort for Asthma, COPD FDA Approves Generic Symbicort for Asthma, COPD

The US Food and Drug Administration (FDA) approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in […]
March 15, 2022

FDA Clears Once-Weekly Transdermal Patch for Alzheimer’s FDA Clears Once-Weekly Transdermal Patch for Alzheimer’s

The US Food and Drug Administration (FDA) has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease (AD), the manufacturer has […]
March 14, 2022

FDA Warns About Using Device Off-Label for Aesthetic Treatment FDA Warns About Using Device Off-Label for Aesthetic Treatment

The US Food and Drug Administration (FDA) has issued a warning about the off-label use of the Renuvion/J-Plasma device for dermal resurfacing and skin contraction procedures. […]
March 14, 2022

FDA Approves First PARP Inhibitor for Early BRCA+ Breast Cancer FDA Approves First PARP Inhibitor for Early BRCA+ Breast Cancer

The PARP inhibitor olaparib (Lynparza) is now approved by the US Food and Drug Administration (FDA) for use in early-stage breast cancer as well as later-stage […]
March 11, 2022

New Contact Lens Elutes Antihistamine for Ocular Allergy New Contact Lens Elutes Antihistamine for Ocular Allergy

The US Food and Drug Administration has approved a new contact lens that elutes the antihistamine ketotifen as a treatment for ocular allergy. “This is the […]
March 10, 2022

FDA Approves Rika System, a Novel Plasma Collection Device FDA Approves Rika System, a Novel Plasma Collection Device

The US Food and Drug Administration has approved a novel plasma collection device designed to meet the rapidly increasing demand for human plasma-based therapies. The Rika […]
March 9, 2022

Medtronic Recalls TurboHawk Directional Atherectomy System Medtronic Recalls TurboHawk Directional Atherectomy System

Medtronic has recalled 686 TurboHawk Plus Directional Atherectomy Systems because there is a risk that the guidewire within the catheter may move downward or prolapse during […]
March 5, 2022

FDA Approves Neoadjuvant Nivolumab/Chemo for Early-Stage NSCLC FDA Approves Neoadjuvant Nivolumab/Chemo for Early-Stage NSCLC

The US Food and Drug Administration (FDA) has approved nivolumab for neoadjuvant treatment of non-small cell lung cancer (NSCLC) in combination with platinum-doublet chemotherapy, regardless of […]
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