regulatory approval

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SGLT latecomer Lexicon gets heart failure okay

Lexicon Pharma tried and failed to get FDA approval for its SGLT inhibitor sotagliflozin for diabetes, but it has finally got the drug over the finish line – for a differe

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Innoviva gets FDA nod for pneumonia antibiotic

The FDA has given a green light to Innoviva’s antibiotic combination Xacduro, which becomes the first drug specifically approved for pneumonia caused by hard-to-treat bact

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Swing’s digital therapy for fibromyalgia gets FDA nod

Swing Therapeutics has joined the ranks of digital therapeutics (DTx) developers with an FDA-approved product, after the regulator greenlit its Stanza app for people with

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FDA clears Vyjuvek as first topical gene therapy

The FDA has approved Krystal Biotech’s gene therapy Vyjuvek for dystrophic epidermolysis bullosa (DEB), a rare genetic disease characterised by fragile skin that can split

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Astellas breaks new ground in menopause with Veozah

Astellas has become the first drugmaker to bring a drug in the neurokinin 3 (NK3) receptor antagonist class to the US market, after getting FDA approval of fezolinetant fo

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Biogen gets FDA approval for ALS drug Qalsody

After much deliberation, the FDA has granted accelerated approval for Biogen’s tofersen for an ultra-rare form of the neurodegenerative disease amyotrophic lateral scleros

SGLT latecomer Lexicon gets heart failure okay

Innoviva gets FDA nod for pneumonia antibiotic

Swing’s digital therapy for fibromyalgia gets FDA nod

FDA clears Vyjuvek as first topical gene therapy

Astellas breaks new ground in menopause with Veozah

Biogen gets FDA approval for ALS drug Qalsody

Beacon's XLRP gene therapy set for filing after phase 3 win

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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