regulatory approval

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Futura gets FDA nod for OTC erectile dysfunction therapy

Futura Medical has become the first company in the US to bring a topical erectile dysfunction therapy to market that does not require a prescription.

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GSK claims first EU approval for an RSV vaccine

GSK’s Arexvy has become the first vaccine for respiratory syncytial virus (RSV) to be approved in the EU, getting the nod from the European Commission for use in older adu

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Cosentyx nod ends 10-year drought in new biologics for HS

Novartis’ IL-17 inhibitor Cosentyx has become the first new biological therapy for the painful skin condition hidradenitis suppurativa (HS) in nearly a decade, following i

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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

Futura gets FDA nod for OTC erectile dysfunction therapy

GSK claims first EU approval for an RSV vaccine

Cosentyx nod ends 10-year drought in new biologics for HS

SGLT latecomer Lexicon gets heart failure okay

Innoviva gets FDA nod for pneumonia antibiotic

Swing’s digital therapy for fibromyalgia gets FDA nod

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regulatory approval

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