regulatory approval

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J&J, Legend get EU nod for myeloma CAR-T Carvykti

Johnson & Johnson and Legend Biotech will arrive at next week's ASCO congress with a new EU approval for multiple myeloma CAR-T Carvykti.

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Dermavant claims its first approval as FDA clears psoriasis ...

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in th

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Angle claims FDA okay for Parsortix liquid biopsy system

After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first ever in the US for a device used to detect

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Dupixent claims new territory in eosinophilic oesophagitis

Sanofi and Regeneron have added another string to the bow of their immunology blockbuster Dupixent with an FDA approval in eosinophilic oesophagitis (EoE), which could help the drug reach i

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Illustration of the thought processes in the brain

FDA approves first in vitro test for early Alzheimer's disea...

The US FDA has authorised a new test that can detect amyloid plaques in early-stage Alzheimer's disease without the use of PET scans, which expose patients to radiation.

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Takeda spinout Phathom claims its first FDA approvals

Three years after it was formed as a spinout of Japanese drugmaker Takeda, Phathom Pharmaceuticals has racked up its first FDA approvals, and claimed a sizeable $260 million in new financin

J&J, Legend get EU nod for myeloma CAR-T Carvykti

Dermavant claims its first approval as FDA clears psoriasis ...

Angle claims FDA okay for Parsortix liquid biopsy system

Dupixent claims new territory in eosinophilic oesophagitis

FDA approves first in vitro test for early Alzheimer's disea...

Takeda spinout Phathom claims its first FDA approvals

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

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