Phase III AB09004 study of Masican shows efficacy and safety in mild-to-moderate Alzheimer’s disease.
FDA approves Twyneo to treat acne vulgaris.
ILLUMINATE-C phase III open-label study of Oxlumo shows efficacy in primary hyperoxaluria type 1.
FDA approves Uptravi IV for pulmonary arterial hypertension.
FDA approves expanded Botox label to include eight new muscles
Biocon Biologics and Viatris Inc. receive FDA approval for first interchangeable biosimilar Semglee
Opdivo indication for hepatocellular carcinoma (liver cancer) withdrawn from FDA.- BMS
Arvinas Inc., and Pfizer Inc., announce a global collaboration to develop and commercialize PROTAC Protein degrader ARV 471.
European Commission approves Opdivo as adjuvant treatment for esophageal or gastroesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy.- BMS
Merck Inc., announced positive overall survival results from the pivotal phase III KEYNOTE-355 trial evaluating Keytruda, + chemotherapy for the treatment of patients with metastatic triple-negative breast cancer .
Complete Response Letter from FDA for NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.- Ardelyx.
Eli Lilly releases donanemab data from the Phase II TRAILBLAZER-ALZ study, that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline.
Vaxzevria and mRNA COVID-19 vaccines showed similar and favourable safety profiles-AstraZeneca
Vaxzevria showed no increased incidence of thrombosis with thrombocytopenia after second dose for COVID 19.- AstraZeneca
FDA approves fexinidazole as the first all-oral treatment for sleeping sickness.
Kyowa Kirin provides update on application for istradefylline in Europe for the treatment of Parkinson’s.
CHMP recommends Nexviadyme, a treatment for for glycogen storage disease type II
Topline results from the phase IIb ECO-RESET study
FDA approval for Bylvay, the first drug treatment for patients With progressive familial intrahepatic cholestasis.
Bylvay is European Commission approved to treat progressive familial intrahepatic cholestasis.
Japan is the first country to approve casirivimab + imdevimab combination for the treatment of mild to moderate COVID-19.
New Data for Genentech’s Hemlibra reinforce safety profile in people with hemophilia A.
Four-year Biktarvy data presented at IAS 2021
New phase III data support the sustained, long-acting efficacy of lenacapavir
EMA validates MAA for valoctocogene roxaparvovec.
Alexion announces positive results from phase III study of Ultomiris.
bluebird bio announces positive recommendation by EU PRAC committee regarding safety referral review of Zynteglo for transfusion-dependent beta-thalassemia and marketing to resume in EU.bluebird bio announces positive recommendation by EU PRAC committee
Biosimilars: an option to alleviate the heavy burden of immune-mediated inflammatory diseases
Clinical value beyond price alone: biosimilars improve patient access to treatment
Long-term topical management of psoriasis: the road ahead
Over the horizon: early stage trials for NASH
Phase II trials and stem cell therapies
The next global epidemic
The latest treatments in NASH
The future of organ transplantation
Complications of stem cell transplants
Treating rejection in organ transplants
Challenges in transplant organ rejection
Biologic efficacy for complications associated with moderate-to-severe psoriasis
Moderate-to-severe psoriasis: treatment for young women
Migraine treatments: On the horizon
An independent review of current treatments for migraine
Migraine: The forgotten epidemic?
NEW: Moderate to Severe Asthma Learning Zone launches on Medthority.com