FDA grants priority review to Keytruda + Lenvima for advanced endometrial carcinoma.- Merck Inc + Eisai
Versius surgical robot begins first gynaecological procedures in NHS hospital.- CMR Surgical
Pfizer and BioNTech receive Health Canada authorization of COVID-19 vaccine in adolescents.
FDA accepts filing and grants priority review for Keytruda + Lenvima in renal cell carcinoma.- Merck Inc + Eisai
FDA approves Keytruda + Herceptin in HER2-positive gastric or gastroesophageal junction adenocarcinoma.- Merck Inc
Adagio Therapeutics announces ADG 20 Phase 1 data and initiation of global
phase II/III clinical trial of ADG 20 for the prevention of COVID-19.
Merck Inc.at Organon investor day outlines the vision and plans for the new company.
European Commission approves Benlysta for adult patients with active lupus nephritis.- GSK
FDA accepts for review sNDA for Otezla to treat mild-to-moderate plaque psoriasis patients who are candidates for phototherapy or systemic therapy. Amgen
Amryt to acquire Chiasma Inc and with it Mycapssa
Apabetalone demonstrates a positive effect on major CV events in patients with chronic kidney disease.- Resverlogix Corporation
Yondelis approved by TGA in Australia to treat unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma.- Specialised Therapeutics.
MHRA approves Ogluo to treat severe hypoglycaemia in patients with diabetes mellitus.- Xeris Pharma
Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept.
FDA issues Complete Response Letter for tralokinumab for the
treatment of adults with moderate-to-severe atopic dermatitis.- Leo Pharma.
CDSCO in India grants Emergency Use approval for baricitinib + remdesivir to treat COVID 19.-Natco
Update on tofersen clinical program to treat ALS -Biogen
Adverum Biotechnologies provides update on the INFINITY trial evaluating ADVM 022 in patients with diabetic macular edema.
Phase III Beovu data in KESTREL and KITE studies show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept.- Novartis.
Farxiga approved in the US for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes.- AstraZeneca
Reproxalap ophthalmic solution achieves statistical significance for primary and all secondary endpoints in phase III INVIGORATE clinical trial in allergic conjunctivitis- - Aldeyra Therapeutics.
FDA Advisory Committee meeting negative on Opdivo post-sorafenib for hepatocellular carcinoma U.S.
FDA extends the PDUFA date for tenapanor for the control of serum phosphorus in patients with CKD on dialysis.-Ardelyx, Inc.
FDA issues complete response letter for Tysabri supplemental filing in SC form for multiple sclerosis.- Biogen
FDA issues a Complete Response Letter relating to the BLA for PRX 102 for the proposed treatment of Fabry disease.- Protalix BioTherapeutics,
FDA Oncologic Drugs Advisory Committee voted in favor of maintaining accelerated approval of Tecentriq + Abraxane, for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. Genentech/Roche
FDA oncological drugs advisory committee votes in support of Tecentriq in bladder cancer.- Genentech/Roche
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
Senolytics: Can we treat age-related diseases with a single drug