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Human Drugs

FDA Requires New Seizure Warning for Parkinsons Drugs

FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause vitamin B6 deficienc...

Biologics

Pfizer, Valneva to File BLA for Lyme Disease Vaccine

Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in...

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Human Drugs

Priority Review for Ionis Alexander Disease Drug

FDA grants a priority review to an Ionis Pharmaceuticals NDA for zilganersen, an experimental treatment for Alexander disease.

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Human Drugs

FDA to Convene Public Meeting on Expanding OTC Drug Access

FDA hosts a public meeting next month aimed at exploring ways to expand access to nonprescription medications.

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Human Drugs

Senator Raises Concerns Over Chinese Biotech Firms in U.S. Clinical Trials

U.S. Senator Rick Scott (R-FL) urges FDA and other federal health agencies to review and tighten oversight of clinical trials and drug approvals invol...

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Human Drugs

FDA OKs Opdivo for Previously Untreated Hodgkin Lymphoma

FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for use with doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients 12 years...

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Human Drugs

FDA Schedules Public Hearing on Commissioners Voucher Program

FDA is announcing a 6/12 public hearing to gather input on its Commissioners National Priority Voucher Pilot Program.

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Human Drugs

Lilly Retatrutide Meets Key Primary, Secondary Endpoints

Lilly says its investigational type 2 diabetes triple agonist retatrutide met its key primary and secondary endpoints in a Phase 3 trial.

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Medical Devices

Warning Letter Cites Right-to-Try Law

Two Mintz attorneys say a CDRH Warning Letter to a medical device sponsor of clinical research and compassionate use protocols may be the first time t...

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Human Drugs

FDA Approves First Treatment for Debilitating Itch in Liver Disease

FDA approves GSKs Lynavoy (linerixibat), the first U.S.-authorized therapy specifically for cholestatic pruritus in patients with primary biliary chol...