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Priority Review for Rare Vision-Loss Disorder Drug

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FDA accepts for priority review a Chiesi NDA for idebenone and its use in treating Leber hereditary optic neuropathy.

FDA Rejects sNDA for Rexultis Use in PTSD

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FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic s...

FDA Takes Actions to Curb Autism

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FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovo...

Rep. Pallone Blasts RFK Jr. Over Vaccine Changes

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Rep. Frank Pallone Jr. (D-NJ) sharply criticizes Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of underm...

FDA OKs Medtronics Altaviva Implant for Incontinence

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FDA approves Medtronics Altaviva implantable tibial neuromodulation device for treating urge urinary incontinence.

10/9 Vaccines Panel to Recommend Flu Strain Selection

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FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain sel...

Mercks Keytruda Qlex Approved by FDA

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FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatr...

Device Inspections Show Tougher Enforcement: Law Firm

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FDA escalates medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in o...

FDA Reverts Lab Test Reg. After Court Ruling

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FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.

FDA OKs Expanded Labeling for Asthma Drug

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FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% red...