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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...

FDA Extends Review on Sanofi Multiple Sclerosis NDA

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FDA extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted r...

Roches Giredestrant Shows Promise in Breast Cancer

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Roche reports positive Phase 3 data with its investigational breast cancer drug giredestrant.

FDA Issues Guidance on Malaria Drug Development

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FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies develop...

Lexicon Submits New Data to FDA on Zynquista

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Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an e...

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.

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...