Results from pivotal phase II KarMMa study of idecabtagene vicleucel to treat refractory multiple myeloma were published in NEJM. - bluebird bio + BMS
Merck Inc. to acquire Pandion Therapeutics including PT 101 for the potential treatment of ulcerative colitis and other autoimmune diseases.
Pfizer Inc. + BioNTech SE announced that the first participants have been dosed in a global phase II/III study to evaluate the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 in pregnant women 18 years of age and older .
TicoVac filed with FDA for tick-borne encephalitis.- Pfizer
Otonomy announces top-line results for the phase III clinical trial of Otividex in patients with Ménière's disease.
Cassava Sciences announces positive end-of-phase II meeting with FDA and outlines pivotal phase III program for simufilam in Alzheimer’s disease.
MHRA (UK) approves Tukysa for the treatment of advanced HER2-positive breast cancer.- Seagen
Phase III U-ACCOMPLISH study of Rinvoq meets primary endpoint in ulcerative colitus.- AbbVie
Incyte announces acceptance and priority review of sNDA for Jakafi as a treatment for patients with chronic graft-versus-host disease.
Adial Pharma to file at FDA for Fast Track review for AD 04 a treatment of alcohol use disorder.
Health Canada approves Reblozyl to treat transfusion-dependent anemia resulting from low/intermediate risk myelodysplastic syndromes. - BMS.
scPharmaceuticals Inc. announces results of type A end-of-review meeting with FDA regarding Furoscix, a treatment for edema in patients with heart failure.
NMPA regulatory agency for China granted conditional approval for toripalimab to treat recurrent or metastatic nasopharyngeal carcinoma.- Shanghai Junishi Biosciences
FDA approves Libtayo to treat non small cell lung cancer.-Regeneron + Sanofi
Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US.- AstraZeneca
Sanofi and GSK announced the initiation of a new phase II study to select the most appropriate antigen dosage for phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine.
Cortexyme provides regulatory update on development program for atuzaginstat in Alzheimer’s disease.
Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the FDA.
Phase III pivotal SKYLIGHT 1 and SKYLIGHT 2 trials of ESN 364 meet endpoints in menopause.- Astellas Pharma
FDA accepts NDA and priority review for Jakavi in atopic dermatitis.- Incyte
Tirzepatide significantly reduced A1C and body weight in type 2 diabetes in two phase III trials from the SURPASS program.- Eli Lilly
Pivotal Phase III ADVOCATE study of CCX 168 in vasculitis published in NEJM.- ChemoCentryx
Lilly and Rigel enter strategic collaboration to develop RIPK1 inhibitors for the treatment of immunological and neurodegenerative diseases.
Phase III LIBERTY 1 and LIBERTY 2 studies of Orgovyx in uterine fibroids published in NEJM.- Sumitovant Biopharma
Ultragenyx announces Canadian approval of Dojolvi to treat long-chain fatty acid oxidation disorders in adults and children.
OlympiA phase III trial of Lynparza for the treatment of BRCA-mutated high-risk HER2-negative early breast cancer will reported early.- AstraZeneca + Merck Inc.
BeiGene announces FDA acceptance of supplemental NDA for Brukinsa for Waldenström’s Macroglobulinemia.
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
Long-term disease control in Psoriasis: announcing a new project
