regulatory approval

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Geron finally brings a drug to market as FDA clears Rytelo

More than 30 years after it was first founded, Geron has claimed FDA approval for its first product – myelodysplastic syndromes (MDS) treatment Rytelo.

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Moderna gets FDA okay for RSV vaccine mResvia

Moderna has secured FDA approval for its respiratory syncytial virus (RSV) vaccine, giving it a chance to generate revenue from a second product as sales of its Spikevax C

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Lilly’s Retevmo cleared for RET-positive child cancers

The US FDA has given accelerated approval for Eli Lilly’s RET inhibitor as a treatment for various RET-altered paediatric cancers, making it the first drug in the class av

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FDA clears Amgen’s Bkemv as first biosimilar of Soliris

The US FDA has approved the first biosimilar version of AstraZeneca/Alexion’s Soliris therapy for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemi

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Lung disease imaging AI from Brainomix gets FDA nod

Artificial intelligence company Brainomix has claimed FDA approval for e-Lung, which assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from me

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Amgen adds BiTE to its cancer range as FDA clears Imdelltra

Amgen has doubled its range of bispecific T-cell engager (BiTE) drugs with the FDA approval of tarlatamab for advanced small cell lung cancer (SCLC) after a priority revie

Geron finally brings a drug to market as FDA clears Rytelo

Moderna gets FDA okay for RSV vaccine mResvia

Lilly’s Retevmo cleared for RET-positive child cancers

FDA clears Amgen’s Bkemv as first biosimilar of Soliris

Lung disease imaging AI from Brainomix gets FDA nod

Amgen adds BiTE to its cancer range as FDA clears Imdelltra

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory approval

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