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FDA Fast Track for eFFECTORs Zotatifin

[ Price : $8.95]

FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or t...

FDA Checking Chinese Syringe Safety

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FDA says it is evaluating possible safety issues with some plastic syringes manufactured by several firms in China.

Chief Scientist Tapped as Woodcock Replacement

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FDA commissioner Robert Califf names agency chief scientist Namandj Bumpus as the replacement for retiring principal deputy commis...

More Novo Nordisk Semaglutide Legal Actions

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Novo Nordisk says it is seeking legal action against two compounding pharmacies it says are selling adulterated and misbranded dru...

AbbVie Seeks Accelerated OK for Lung Cancer Drug

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Based on new clinical study data, AbbVie says it will seek accelerated approval for telisotuzumab-vedotin in patients with c-Met p...

Info Collection on Combination Product Jurisdiction

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Federal Register notice: FDA sends to OMB an information collection extension entitled Product Jurisdiction and Combination Produc...

UCB on Pregnancy Safety Studies

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UCB makes suggestions for FDA to consider in developing a framework to optimize post-approval pregnancy safety studies.

FDA Clears GE Critical Care Suite 2.1

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FDA clears GE Healthcares Critical Care Suite 2.1 that includes a pneumothorax algorithm.

Arcturus Therapeutics Orphan Status for ARCT-032

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FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.

Regulatory Review Determinations on 8 NDAs

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Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsore...