regulatory approval

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Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

AstraZeneca’s Tagrisso can be used alongside chemotherapy as a frontline therapy for EGFR-positive non-small cell lung cancer (NSCLC), according to the FDA, consolidating

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New era for cell therapy as FDA OKs first for solid tumours

Iovance Biotherapeutics has carved out a piece of biotech history, becoming the first company to win FDA clearance for a cell therapy used to treat a solid tumour.

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First drug therapy for frostbite has been cleared by FDA

People at risk of losing a finger or toe to frostbite now have the first FDA-approved treatment that could prevent a life-changing amputation.

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Onivyde gets ‘practice-changing’ FDA OK in pancreatic cancer

Ipsen has won FDA approval for first-line use of its pancreatic cancer therapy Onivyde, saying it is now part of a potential new “standard-of-care” for patients.

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Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia

After getting a green light from the European Commission, Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA)

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FDA changes its mind and approves Takeda’s Eohilia

In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE).

Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

New era for cell therapy as FDA OKs first for solid tumours

First drug therapy for frostbite has been cleared by FDA

Onivyde gets ‘practice-changing’ FDA OK in pancreatic cancer

Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia

FDA changes its mind and approves Takeda’s Eohilia

GBL joins CVC in €10.7bn takeover bid for Recordati

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

regulatory approval

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