regulatory approval

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Relief for AZ, Amgen as FDA okays severe asthma hope tezepel...

The FDA has approved AstraZeneca and Amgen's severe asthma hope tezepelumab, exonerating the drugmakers' decision to press ahead with a regulatory filing despite a failed phase 3 trial.

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BMS' Orencia gets FDA nod for GvHD thanks to real-world data

Bristol-Myers Squibb's rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transpl

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EU gives narrower label to Apellis, Sobi's PNH drug

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US.

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EU approves Roche's Actemra for severe COVID-19

The European Commission has moved swiftly to grant full approval to Roche's Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours of a recommendation from

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Merck claims another adjuvant okay from FDA for Keytruda

Merck & Co's strategy of pushing Keytruda earlier in the treatment pathway for cancers has secured anther victory, after the FDA approved the immunotherapy for adjuvant treatment of ski

Market Access

scientifically visualization of a coronavirus spike protein

MHRA okays GSK's Xevudy as data suggest it works against Omi...

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech's antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in

Relief for AZ, Amgen as FDA okays severe asthma hope tezepel...

BMS' Orencia gets FDA nod for GvHD thanks to real-world data

EU gives narrower label to Apellis, Sobi's PNH drug

EU approves Roche's Actemra for severe COVID-19

Merck claims another adjuvant okay from FDA for Keytruda

MHRA okays GSK's Xevudy as data suggest it works against Omi...

Ipsen licenses Simcere ADC in $1bn-plus deal

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regulatory approval

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