
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.
FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.
FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.
The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.
FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.
GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.
The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.
Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.
EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.
Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.
EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).
After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.
EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.
FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.
Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.
FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.
The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.