regulatory approval

News

Chasing AbbVie, Roche gets FDA OK for DLBCL bispecific

Roche has claimed FDA approval for its CD20xCD3 bispecific antibody Columvi as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), setting up an

News

Ipsen gets second FDA approval for itch drug Bylvay

It’s a case of so far, so good for Ipsen with its recent acquisition of Albireo, after the main asset in the deal – Bylvay – secured FDA approval for its second rare disea

News

Futura gets FDA nod for OTC erectile dysfunction therapy

Futura Medical has become the first company in the US to bring a topical erectile dysfunction therapy to market that does not require a prescription.

News

GSK claims first EU approval for an RSV vaccine

GSK’s Arexvy has become the first vaccine for respiratory syncytial virus (RSV) to be approved in the EU, getting the nod from the European Commission for use in older adu

News

Cosentyx nod ends 10-year drought in new biologics for HS

Novartis’ IL-17 inhibitor Cosentyx has become the first new biological therapy for the painful skin condition hidradenitis suppurativa (HS) in nearly a decade, following i

News

SGLT latecomer Lexicon gets heart failure okay

Lexicon Pharma tried and failed to get FDA approval for its SGLT inhibitor sotagliflozin for diabetes, but it has finally got the drug over the finish line – for a differe

Chasing AbbVie, Roche gets FDA OK for DLBCL bispecific

Ipsen gets second FDA approval for itch drug Bylvay

Futura gets FDA nod for OTC erectile dysfunction therapy

GSK claims first EU approval for an RSV vaccine

Cosentyx nod ends 10-year drought in new biologics for HS

SGLT latecomer Lexicon gets heart failure okay

GBL joins CVC in €10.7bn takeover bid for Recordati

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

regulatory approval

Editor's Picks