Gene therapy player AveXis has gotten a Breakthrough Therapy Designation for its only clinical candidate, AVXS-101 to treat spinal muscular atrophy Type 1.

Troubled Canadian specialty pharma company Valeant has won U.S. approval for a new oral formulation of the previously injectable-only med Relistor for certain…

An FDA advisory committee recommended that the agency approve Valeant’s brodalumab to treat moderate-to-severe plaque psoriasis.

Buried deep down in Novartis’ Q2 results out this morning was a previously unknown rejection by the FDA for a copycat version of Amgen’s blockbuster drug…

George Freeman has left the post of minister for life sciences as part of a reshuffle initiated by the new U.K. prime minister in the wake of the Brexit vote.

Another day, another unanimous FDA panel vote, this time recommending Novartis’ Enbrel (etanercept) biosimilar be approved across all of its U.S. licenses.

Kite Pharma has said it has no concerns with its recently enrolled experimental CAR-T trial that is using a chemo drug now dropped by rival Juno after it…

Amgen took one step closer to approval for its biosimilar of the world’s biggest-selling drug last night, but analysts don’t see it hitting the market this…