FDA grants Advaite emergency use authorization for RapCov Rapid COVID-19 Test.
Mateon announces positive interim results from ARTI-19 clinical trial evaluating ARTIVeda as a COVID-19 therapeutic.
FDA approves expansion of indication for Enhertu in metastatic HER2-positive gastric or gastroesophageal adenocarcinoma.- AstraZeneca/Daiichi Sankyo
FDA approves Darzalex Faspro combination treatment for light chain (AL) amyloidosis.- Janssen Biotech
FDA gives regulatory feedback for phase III SOLOIST and SCORED trials of Zynquista in CV risk with type 2 diabetes.- Lexicon Pharma
Imfinzi approved in the EU and UK for less-frequent, fixed-dose use in unresectable non-small cell lung cancer.- AstraZeneca
United Therapeutics announces NEJM publication of the INCREASE study for Tyvaso in pulmonary hypertension associated with interstitial lung disease.
FDA grants priority review to NDA for finerenone to treat patients with chronic kidney disease and type 2 diabetes.- Bayer HealthCare.
Phase III clinical trial of Lumevoq in Leber Hereditary Optic Neuropathy published in Ophthalmology journal.- GenSight Biologics
CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV.
Xalkori approved by the FDA for treatment of pediatric and young adults with relapsed/refractory ALK positive anaplastic large cell lymphoma.- Pfizer.
China National Medical Products Administration approves tislelizumab in combination with chemotherapy in first-line advanced squamous non-small cell lung cancer.- BeiGene Ltd.
BioMerica's COVID-19 IgG/IgM Rapid Test receives CE Mark and provides results in 15 minutes.
Enrollment halted in global phase III trial of Ultomiris in COVID-19.- Alexion Pharmaceuticals
EU gives extended approval for formulation of Tivicay for paediatric patients with HIV.- ViiV Healthcare
FDA indicates phase III Marigold Study of oral ganaxolone supports filing in CDKL5 deficiency disorder.- Marinus Pharma
NIDA-funded study evaluating extended-release injectable naltrexone + bupropion for the treatment of methamphetamine use disorder is published in NEJM.- Alkermes
Boston Scientific launches WaveWriter Alpha Spinal Cord Stimulator Systems in the US to manage chronic intractable pain.
FDA accepts for priority review the BLA for V114, investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older. - Merck Inc.
EMA validates MAA for Opdivo as adjuvant treatment for resected esophageal or gastroesophageal junction cancer following chemoradiotherapy.- BMS
Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer.
In vitro study shows Pfizer-BioNTech SE COVID 19 vaccine elicits antibodies that neutralise COVID-19 with a mutation associated with rapid transmission.
Arcutis initiates pivotal phase III clinical trials for topical roflumilast cream (ARQ 151) as a potential treatment for atopic dermatitis.
Allergan Aesthetics has option to acquire Cypris Medical and Xact surgical device
Novartis expands oncology pipeline with in-licensing of tislelizumab from BeiGene.
BioMarin announces positive phase III GENEr8-1 study results of valoctocogene roxaparvovec gene therapy in adults with severe hemophilia A.
Lilly's donanemab slows clinical decline of Alzheimer's disease in positive phase II trial.
Dysbiosis and Clostridioides difficile: Managing the burden of disease
Clostridioides difficile recurrence: Alternative microbiome-based therapies
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?
