Jazz Pharmaceuticals + PharmaMar announce results of ATLANTIS phase III study of Zepzelca + doxorubicin for small cell lung cancer.
Genmab announces that Janssen has submitted a BLA to the FDA for amivantamab in non-small cell lung cancer.
PROTECTIVE-2 Phase III study of plinabulin + pegfilgrastim met the primary endpoint in neutropenia.- BeyondSpring
Ovid Therapeutics announces phase III NEPTUNE clinical trial of OV 101 for the treatment of Angelman syndrome did not meet primary endpoint.
Pfizer and BioNTech achieve first authorisation in the world from MHRA in the UK for BNT 162b2 mRNA vaccine against COVID-19
FDA approves Hetlioz for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome.- Vanda Pharma.
Boston Scientific Corporation sells its BTG Specialty Pharmaceuticals business to SERB SA.
Genentech announces FDA approval of supplemental BLA of Xolair for add-on maintenance treatment of nasal polyps.
Minerva Neurosciences announces outcome of Type C meeting with FDA and next steps in the development of roluperidone for treatment of negative symptoms in schizophrenia.
Accelerated FDA approval for Gavreto to treat (RET)-mutant medullary thyroid cancer .- Genentech
Novavax announces COVID-19 vaccine clinical development progress of NVX CoV2373.
FDA grants accelerated approval for Danyelza to treat with GM-CSF, pediatric patients with high risk neuroblastoma.-Y-mAbs Therapeutics, Inc.
FDA approves INTERCEPT Blood System for control of bleeding.- Cerus Corp
European Commission approves Dupixent as first and only biologic medicine for children with severe atopic dermatitis.-Sanofi + Regeneron
Moderna announces primary efficacy analysis in phase III COVE study for mRNA 1273 vaccine candidate and filing today with the FDA for Emergency Use Authorization.
Forxiga approved in Japan for heart failure in patients with reduced ejection fraction.- AstraZeneca
GRAIL and UK Government to make Galleri multi-cancer early detection blood test available in the UK.- GRAIL Inc.,
FDA extends PDUFA date for PRX 102 in Fabry Disease.- Protalix BioTherapeutics and Chiesi
NICE does not recommend NHS use of Adakveo in sickle cell disease.- Novartis
EU approves Symkevi + Kalydeco for eligible children with cystic fibrosis.- Vertex
FDA approves Imcivree for obesity due to POMC, PCSK1 or leptin receptor (LEPR) deficiencies confirmed by genetic testing.- Rhythm Pharmaceuticals
European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations.- Merck KGaA.
NICE recommends use of Sarclisa plus pomalidomide and dexamethasone for multiple myeloma .- Sanofi
WHO Solidarity trial and WHO recommendations find no evidence to support remdesivir and other re-purposed drugs to improve COVID-19 outcomes.
Efficacy reports of Sputnik V vaccine for Covid-19 show 91.4% efficacy from a second interim analysis of more than 18,000 people.- Gamaleya National Center of Epidemiology and Microbiology.
Phase III IMCgp100-202 study of IMCgp100 shows statistical improvement in metastatic uveal melanoma.- Immunocore
Merck Inc., submits applications for licensure of V 114, an investigational 15-valent pneumococcal conjugate vaccine to the FDA and EMA.
Long-term topical management of psoriasis: the road ahead
The importance of microbiome diversity
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
