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Biden Taps Ex-FDA Head Califf as Next Commissioner

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The Biden Administration chooses former FDA head Robert Califf as its FDA commissioner nominee.

Apellis NDA Planned for Geographic Atrophy

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Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating a blind...

Foreign Study Sites Escape FDA Oversight: Professor

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A Journal of Clinical Pharmacology study finds that FDA has less oversight of overseas clinical trials that are used to form the b...

PharmaEssentia BLA Approved for Blood Disease

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FDA approves a PharmaEssentia BLA for Besremi injection to treat adults with polycythemia vera, a blood disease associated with re...

Novavax Expects U.S. Covid Vaccine Filing Soon

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Novavax requests a meeting with FDA in advance of filing for approval of its Covid-19 vaccine.

PureTech Orphan Status for Pancreatic Cancer Drug

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FDA grants PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer.

Topline Data Confirm Semorinemab Effect on Alzheimers

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Data presented by Genentech show AC Immunes semorinemab reduced cognitive decline compared to placebo in a Phase 2 Alzheimers dise...

Dont Approve Eagle Vasostrict ANDA Yet: Par

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Par asks FDA not to approve an Eagle ANDA referencing Vasostrict until specified changes are made regarding the pH specification.

Oklahoma Court Overturns J&J Opioid Case Ruling

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The Oklahoma Supreme Court says a lower court erred in determining that J&J violated the states public nuisance law in the way it ...

Rivoceranib Gets Orphan Status for Liver Cancer

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FDA grants Elevar Therapeutics an orphan drug designation for rivoceranib and its use for treating hepatocellular carcinoma.