regulatory approval | pharmaphorum

Wednesday 1 April 2026

regulatory approval

News

Squamous-cell carcinoma

Regeneron's Libtayo stakes out new territory in skin cancer

Regeneron's Libtayo has become the first checkpoint inhibitor to be cleared by the FDA as an adjuvant treatment for cutaneous squamous cell carcinoma.

News

Boehringer bags FDA okay for new pulmonary fibrosis drug

Boehringer bags FDA okay for new pulmonary fibrosis drug

Boehringer's successor to blockbuster IPF therapy Ofev has been approved by the FDA as Jascayd, but will the new drug be a commercial success?

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Roche gets EU nod for kidney disease algorithm

Roche and Klinrisk have picked up a CE-mark for an AI tool that can be used to predict renal function decline in patients with chronic kidney disease.

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Jazz, Roche combo cleared by FDA for lung cancer

Jazz, Roche combo cleared by FDA for lung cancer

Can FDA approval of Jazz Pharma's Zepzelca in a combination regimen for extensive-stage small cell lung cancer return sales of the drug to growth?

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FDA angers anti-abortion lobby with generic abortion pill OK

FDA angers anti-abortion lobby with generic abortion pill OK

The FDA has cleared another generic of the abortion pill mifepristone, as it carries out a review of the drug that has been criticised as spurious.

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FDA clears Novartis' oral drug for chronic hives

Novartis has claimed a first-in-class approval in the US for its oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria.