regulatory approval

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Sanofi extends its Pompe range with first Nexviazyme OK

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder.

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West Chester - Circa November 2020: AstraZeneca plant. AstraZeneca has been working on a vaccine for the Coronavirus, COVID and COVID-19.

FDA approves AZ's anifrolumab, ending 10-year lupus drug dro...

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the a

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After false start, Merck claims Keytruda approval in early b...

Merck & Co's Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of th

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GSK wants to double Shingrix sales, and a new FDA okay could...

The FDA has approved GlaxoSmithKline's shingles vaccine Shingrix for use in people aged under 50 who are immunocompromised – a key step in the UK drugmaker's plan to build the shot into a £

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Bluebird claims EU nod for rare disease therapy Skysona

Bluebird bio has its first approval for Skysona (formerly Lenti-D), its gene therapy for children with the rare disease cerebral adrenoleukodystrophy (CALD), after getting the nod from the

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Bayer's finerenone gets FDA nod for diabetic kidney disease

Bayer's big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff compe

Sanofi extends its Pompe range with first Nexviazyme OK

FDA approves AZ's anifrolumab, ending 10-year lupus drug dro...

After false start, Merck claims Keytruda approval in early b...

GSK wants to double Shingrix sales, and a new FDA okay could...

Bluebird claims EU nod for rare disease therapy Skysona

Bayer's finerenone gets FDA nod for diabetic kidney disease

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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