The FDA has given Roche its first regulatory approval for PI3K inhibitor Itovebi, clearing the drug as part of a triple therapy for certain types of locally advanced or metastatic breast ca
Bristol-Myers Squibb's $14 billion bet on buying Karuna Therapeutics looks set to pay off after it got FDA approval for the schizophrenia drug at the heart of the deal.
AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targete
In the space of four days, the number of FDA-approved therapies for ultra-rare genetic disorder Niemann-Pick disease has gone from zero to two, transforming the prospects for patients.
After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagill