regulatory approval

News

Leo puts target on Dupixent in US as FDA clears tralokinumab

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma's rival antibody tralokinumab.

News

Novartis bags elusive US approval for cholesterol drug incli...

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year.

News

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.

News

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

News

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.

News

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

Leo puts target on Dupixent in US as FDA clears tralokinumab

Novartis bags elusive US approval for cholesterol drug incli...

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

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

Editor's Picks