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With FDA nod, Tonix's Tonmya becomes first new fibromyalgia treatment in more than 16 yearsTonix Pharmaceuticals was founded in 2010 to develop and bring to market a drug for fibromyalgia. Fifteen years later, the New Jersey company has accomplished its mission with the FDA's endorsement o2025/8/19
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CDMO OXB raises £60M to support US expansion ambitionsWith 60 million pounds sterling ($81.4 million) raised through recent share sales, the CDMO OXB has its eyes on a U.S. expansion. In a sizable share placement, the cell and gene therapy-focused compa2025/8/19
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Precigen scores FDA nod for first-ever treatment for HPV-related disorderFor the first time, the FDA hasapproveda treatment for recurrent respiratory papillomatosis (RRP), a rare, chronic disease that causes benign tumors, most commonly in the voice box, and can force som2025/8/14
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HHS revives '90s task force designed to improve safety of childhood vaccinesThe Department of Health and Human Services (HHS) is relaunching a task force focused on the safety of childhood vaccines. The federal panel will be chaired by National Institutes of Health (NIH) Dir2025/8/14
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Trump's drug tariff announcement still 'weeks away': ReutersTrump's drug tariff announcement still 'weeks away': ReutersPresident Donald Trump’s announcement about tariffs on pharmaceutical goods imported to the United States is delayed. Despite a threat from the President early last week that the tariff disclosure wo2025/8/12
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China did not renew approval of controversial Alzheimer's drug, regulator's records showChinese authorities did not renew a conditional approval of Green Valley Pharmaceuticals’ controversial Alzheimer’s disease drug sodium oligomannate, also known as GV-971, according to online records2025/8/12
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RemeGen's telitacicept meets the mark in phase 3 Sjögren's study in ChinaVor Bio’s big bet on RemeGen’s autoimmune asset telitacicept appears well placed after the drug—already approved across three conditions overseas—delivered a late-stage win in a Sjögren's syndrome tr2025/8/7
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Eli Lilly pledges vigorous defense as Texas sues over alleged drug kickbacksIf at first you don’t succeed, try, try again. That seems to be the strategy behind a new lawsuit from Texas Attorney General Ken Paxton and Health Choice Alliance accusing Eli Lilly of “incentivizin2025/8/7
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Insmed’s Brinsupri scores landmark FDA nod in bronchiectasis, marking first approval of a DPP1 inhibitorWith a landmark U.S. approvalTuesday, Insmed is making waves with a new class of drug that’s also the first to be green lit in the chronic lung disease bronchiectasis. The FDA has signed off on Insme2025/8/5
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FDA may not renew Pfizer's pediatric COVID shot authorization, prompting potential complication for child vaccinations this fallThe ability to inoculate young children against COVID-19 in the U.S. may be diminished this fall as the FDA weighs whether to renew the emergency green light for the vaccine currently cleared in the2025/8/5