USA – Using mRNA technology for a universal flu vaccine
Influenza, the virus that causes the flu, can be deadly. Twenty different types of the virus have been identified. Many of these circulate between animals...
USA – FDA finalizes guidance on drug quality consensus standards recognition program
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for...
USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
The US Food and Drug Administration (FDA) on Wednesday authorized bivalent COVID-19 vaccines targeting the Omicron BA.4/5 subvariants developed by Pfizer-BioNTech and Moderna, asserting...
UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark...
For the first time ever in the UK, postmenopausal women will be able to access a low dose Hormone Replacement Therapy (HRT) product from...
USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule
Drugmakers laud the US Food and Drug Administration’s (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities. Compounders,...
USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...
USA – Patients with incurable cancer should be included in trials for new therapies
The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational...
USA – Manufacturers seek clarity on FDA’s drug shortage notification guidance
Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug...
USA – FDA officials offer CMC advice for gene therapies at OTP town hall
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
