Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 18 Oct 2021
United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application
18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning. ...
Posted by Michael Wonder on 18 Oct 2021
Omeros receives complete response letter from FDA for biologics license application for narsoplimab in the treatment of HSCT-TMA
18 October 2021 - Omeros Corporation today announced that the company received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 18 Oct 2021
Revance provides regulatory update on daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar (frown) lines
15 October 2021 - Revance Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 18 Oct 2021
Oyster Point Pharma announces FDA approval of Tyrvaya (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry eye disease
18 October 2021 - Tyrvaya is the first and only nasal spray approved for the treatment of the signs and symptoms ...
Posted by Michael Wonder on 18 Oct 2021
EMA grants PRIME designation for JR-141 for the treatment of mucopolysaccharidosis type II (Hunter syndrome)
18 October 2021 - JCR Pharmaceuticals announced today that the EMA has granted PRIME designation for the investigational drug JR-141 (pabinafusp ...
Posted by Michael Wonder on 18 Oct 2021
Australia secures additional COVID-19 treatments
17 October 2021 - The Australian Government has secured access to two additional COVID-19 treatments to support the National Plan to ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves naloxone injection to counteract opioid overdoses
18 October 2021 - The FDA has approved Zimhi (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
18 October 2021 - The U.S. FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. ...
Posted by Michael Wonder on 18 Oct 2021
NICE approves Ofev for PF-ILD
18 October 2021 - NICE has recommended Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of adult patients with chronic fibrosing ...
Posted by Michael Wonder on 18 Oct 2021
New asthma drug approved on NHS branded a ‘wonder drug’
18 October 2021 - NICE has issued a Final Appraisal Determination recommending dupilumab as an add-on maintenance treatment for severe ...
Posted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
Posted by Michael Wonder on 18 Oct 2021
Novartis applauds Quebec, the first province to list Zolgensma for the treatment of paediatric patients with spinal muscular atrophy
15 October 2021 - Public reimbursement under the Régie de l'assurance maladie du Québec, effective October 20th will apply for children ...
Posted by Michael Wonder on 18 Oct 2021
TGA provisional approval of Roche COVID-19 treatment, casirivimab with imdevimab (Ronapreve)
18 October 2021 - The TGA has provisionally approved the use of the Roche combination therapy, casirivimab + imdevimab (Ronapreve) ...
Posted by Michael Wonder on 17 Oct 2021
FDA needs a competitiveness czar
15 October 2021 - The FDA needs a Deputy Commissioner for Regulatory Competitiveness. ...
Posted by Michael Wonder on 17 Oct 2021
Recent trends in Medicaid spending and use of drugs with US Food and Drug Administration accelerated approval
8 October 2021 - In this cross-sectional study of 216 drugs granted accelerated approval from 1992 through 2020, relative to all ...