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FDA to Convene Public Meeting on Expanding OTC Drug Access

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

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

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

FDA OKs Opdivo for Previously Untreated Hodgkin Lymphoma

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for use with doxorubicin, vinblastine, and dacarbazine for adult and pediatr...

FDA Schedules Public Hearing on Commissioners Voucher Program

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

Lilly Retatrutide Meets Key Primary, Secondary Endpoints

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

Warning Letter Cites Right-to-Try Law

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

FDA Approves First Treatment for Debilitating Itch in Liver Disease

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

Sarepta to Submit Amondys 45 and Vyondys 53 sNDAs

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Sarepta says it will submit to FDA by the end of April sNDAs to convert the accelerated approvals of its Amondys 45 and Vyondys 53...

Novo Nordisks High-Dose Wegovy Approved

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FDA approves a higher-dose version of Novo Nordisks blockbuster weight-loss drug Wegovy (semaglutide) injection.

Rare Disease Advocates Stage Funeral at FDA Headquarters

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Ultrarare disease sufferers and advocates stage a mock funeral at FDA headquarters to grieve the lack of approved treatments for c...