Approves

FDA approves first fast-acting oral drug for clinical depression

FDA approves first fast-acting oral drug for clinical depression

Story at a glance A newly approved treatment for clinical depression is being hailed as a potential game changer for the millions of Americans who suffer from the condition. Auvelity, from Axsome Therapeutics, marks the first drug with a different mechanism of action approved for treating depression in 60 years. In clinical trials, participants reported …

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Fuel Cell Leaders Set To Report, As Senate Approves Climate Bill

Fuel Cell Leaders Set To Report, As Senate Approves Climate Bill

Hydrogen fuel cell stocks Plug Power (PLUG) and Ballard Power Systems (BLDP) spiked Monday. The U.S. Senate approved a sweeping spending bill over the weekend which would direct billions of dollars toward clean energy projects. Both companies are set to report quarterly results this week. X The Senate passed the proposal, titled the Inflation Reduction …

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FDA Denies Authorization to Market JUUL Products

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

For Immediate Release: August 05, 2022 Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast …

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FDA approves new therapy for people living with skin-discoloration disorder vitiligo

FDA approves new therapy for people living with skin-discoloration disorder vitiligo

The U.S. Food and Drug Administration granted approval on Monday for Opzelura, which is the first topical JAK inhibitor cream for the treatment of vitiligo for people 12 and older. Vitiligo, which research estimates 1.9 million to 2.8 million adults in the U.S. have, is an autoimmune disorder caused by antibodies that attack a person’s …

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EU Approves Landmark Legislation to Regulate Apple and Other Big Tech Firms

EU Approves Landmark Legislation to Regulate Apple and Other Big Tech Firms

European Union lawmakers have approved landmark legislation to heavily regulate Apple, Google, Meta, and other big tech firms. The Digital Markets Act (DMA) and Digital Services Act (DSA) were proposed by the European Commission in December 2020. Now, collected in a “Digital Services Package,” the legislation has been formally adopted by the European Parliament and …

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FDA approves first alopecia treatment for condition that causes sudden hair loss

FDA approves first alopecia treatment for condition that causes sudden hair loss

People suffering from a rare autoimmune disorder that causes their hair to suddenly fall out, often in clumps, now have a treatment option for the first time. On Monday, the Food and Drug Administration approved baricitinib, a once-a-day pill developed by the drugmaker Eli Lilly to treat alopecia areata, an autoimmune disease that triggers sudden …

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F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients

F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients

The disease can vary in severity, but for some, it can be life-altering — a total loss of body hair, including eyelashes and eyebrows, even nose hair and hair in the ears. And, until recently, for those with alopecia areata, there was no treatment to make the hair grow back. But on Monday, the Food …

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