regulatory approval

News

Roche's Tecentriq extends lead over Keytruda in adjuvant NSC...

While Merck & Co's Keytruda is the undisputed leader of the non-small cell lung cancer (NSCLC) category, there's one category where it lags behind Roche's Tecentriq – treatment of early

News

EU first to clear Roche's lymphoma bispecific mosunetuzumab

Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the EU.

News

Roche puts pressure on SMA rivals with new FDA approval

Roche and PTC Therapeutics' Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its use to include infants less than

News

BMS' Opdivo gets late-stage oesophageal cancer nod from FDA

The FDA has cleared two combination drug regimens based on Bristol-Myers Squibb's PD-1 inhibitor Opdivo for previously-untreated advanced oesophageal cancer, encroaching on territory held b

News

J&J, Legend get EU nod for myeloma CAR-T Carvykti

Johnson & Johnson and Legend Biotech will arrive at next week's ASCO congress with a new EU approval for multiple myeloma CAR-T Carvykti.

News

Dermavant claims its first approval as FDA clears psoriasis ...

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in th

Roche's Tecentriq extends lead over Keytruda in adjuvant NSC...

EU first to clear Roche's lymphoma bispecific mosunetuzumab

Roche puts pressure on SMA rivals with new FDA approval

BMS' Opdivo gets late-stage oesophageal cancer nod from FDA

J&J, Legend get EU nod for myeloma CAR-T Carvykti

Dermavant claims its first approval as FDA clears psoriasis ...

Delivering the right behavioural ingredients for the moment,...

How to meet your physicians where they are online

regulatory approval

Editor's Picks