FDA approves Benlysta (belimumab) first treatment for pediatric patients with lupus
The U.S. Food and Drug Administration has approved Benlysta (belimumab)…
Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients
Bristol-Myers Squibb has announced results from pooled analyses of survival…
Dovato (dolutegravir and lamivudine), a new complete regimen for HIV-infected patients who have never received antiretroviral treatment
The U.S. Food and Drug Administration has approved Dovato (dolutegravir and…
Mayzent (siponimod) tablets approved by FDA to treat adults with relapsing forms of multiple sclerosis (MS)
The U.S. Food and Drug Administration has approved Mayzent (siponimod) tablets…
Zynteglo, New gene therapy to treat rare inherited blood condition
EMA has recommended granting a marketing authorisation in the European Union…
Merck has announced the FDA approval of its Mavenclad (cladribine) tablets in various forms of multiple sclerosis (MS).
The U.S. Food and Drug Administration has approved Mavenclad (cladribine)…
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic
The U.S. Food and Drug Administration has approved Spravato (esketamine) nasal…
New indication for Dupixent (dupilumab) as add on treatment for patients with severe asthma
EMA’s human medicines committee (CHMP) has recommended granting an extension…
Ondexxya (andexanet alfa), first antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban
EMA’s human medicines committee (CHMP) has recommended granting a conditional…
Waylivra (volanesorsen), first treatment for rare disease characterised by high levels of triglycerides in blood
The European Medicines Agency has recommended granting a conditional…