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<![CDATA[FDA Approves Lerodalcibep, Third-Generation PCSK9 Inhibitor, to Treat Hypercholesterolemia, Including HeFH]]>
19 Dec 2025 00:19 GMT
The FDA announced its approval of lerodalcibep-liga ( … Clinical Trial Program
The FDA based its decision on … development effort behind the approval. “I wish to … he said.
Source: US Food and Drug Administration approves LIP Therapeutics Lerochol (lerodalcibep- …
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CDC awards grant to controversial Danish researchers with ties to top FDA official
19 Dec 2025 01:13 GMT
… Denmark with ties to top Food and Drug Administration official Tracy Beth Høeg … is funding has cleared ethics approval at the University of Southern … Høeg, an adviser to FDA Commissioner Marty Makary who was … . Høeg is also the FDA’s representative on the CDC …
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J&J's subcutaneous Rybrevant cleared by FDA
19 Dec 2025 01:23 GMT
… & Johnson has claimed FDA approval for Rybrevant Faspro, a … , for all the indications approved for the current, intravenous … of Rybrevant has four FDA approvals in previously untreated and … the MARIPOSA readout.
The approval of the subcutaneous version …
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<![CDATA[Generic drug for canine osteoarthritis receives FDA approval]]>
19 Dec 2025 01:34 GMT
… in canines has been approved by FDA officials. Meloxicam Oral Suspension … release.1 “With the approval of Meloxicam Oral Suspension, … option backed by rigorous FDA standards.”
Meloxicam Oral Suspension … dispensed by prescription. The FDA has determined the drug …
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<![CDATA[FDA Approves Amivantamab and Hyaluronidase-lpuj, Revolutionizing Lung Cancer Treatment With 5-Minute Subcutaneous Delivery]]>
18 Dec 2025 22:29 GMT
… cancer care, the FDA has approved amivantamab and hyaluronidase-lpuj … (NSCLC).1
The approval dramatically streamlines the treatment … new SC formulation is approved across all existing indications … mutations.1
This SC approval reinforces the effectiveness …
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The FDA Just Approved a Brain Tumor Warning for This Form of Birth Control
18 Dec 2025 22:12 GMT
“Meningiomas are especially sensitive to progesterone,” Dr. D’Amico explains. “The Depo-Provera shot contains high doses of a synthetic form of progesterone—medroxyprogesterone acetate—that stays in the body for months at a time. In patients that already …
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FDA Updates Depo-Provera Label to Include Brain Tumor Risk — Key Litigation Development
18 Dec 2025 20:57 GMT
The U.S. Food and Drug Administration (FDA) has approved a significant update … and Litigation Context
The FDA’s action comes amid … agency that the FDA did not approve, and courts have … tort litigation.
The Food and Drug Administration approved on Friday a label …
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The Mind, the Machine, and the Model Drift: FDA's Emerging Oversight of Generative AI Mental-Health Devices
18 Dec 2025 20:57 GMT
… hasn't yet approved any generative AI-based tools … through consistent, predictable regulation
FDA will apply a risk-based … enforcement priority
Zooming out, FDA clarified that:
General wellness … might attempt to invoke FDA approval as a shield against …
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Novo Nordisk Files FDA Application For Weekly Combination Obesity Shot
18 Dec 2025 20:36 GMT
… (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema.
The … 2.4 mg.2 If approved, CagriSema would become the first … in the placebo group.
The FDA is expected to review the …
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Lilly obesity pill, headed for quick FDA review, hits mark in ‘maintenance’ trial
18 Dec 2025 20:33 GMT
… Food and Drug Administration to approve orforglipron. The pill was awarded one of the FDA … version of Wegovy to the FDA close to April, meaning … it intended to seek an approval, but the new voucher — … away, even if an FDA approval in the maintenance setting isn …