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 11 Jul 2021
NICE publishes draft guidance on the use of Libmeldy
9 July 2021 - OTL-200 (Libmeldy) is a gene therapy medicinal product that expresses the human ARSA gene. ...
Posted by Michael Wonder on 11 Jul 2021
UK’s MHRA accepts Humanigen’s submission of lenzilumab for marketing authorisation in COVID-19 for expedited rolling review
9 July 2021 - Humanigen today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has ...
Posted by Michael Wonder on 11 Jul 2021
Novartis Korea to continue discussing reimbursement plan for SMA drug Zolgensma
9 July 2021 - Novartis said Friday that it would continue to discuss with the domestic regulators to receive reimbursement ...
Posted by Michael Wonder on 11 Jul 2021
Drug prices are one focus of Biden’s push to boost competition
9 July 2021 - Executive order calls for easing access for generics, Canadian drugs to lower costs. ...
Posted by Michael Wonder on 11 Jul 2021
COVID vaccine rollout: chemists brought in to fast track jabs
11 July 2021 - With Australia’s biggest city in lockdown, chemists have been brought in to fast track the Covid-19 vaccine ...
Posted by Michael Wonder on 11 Jul 2021
EMA advises against use of COVID-19 vaccine Janssen in people with history of capillary leak syndrome
9 July 2021 - EMA’s safety committee has recommended that people who have previously had capillary leak syndrome must not be ...
Posted by Michael Wonder on 10 Jul 2021
FDA seeks to probe talks between staff and Biogen on Alzheimer’s drug
9 July 2021 - The FDA’s chief is taking the highly unusual step of asking for a federal investigation of doctors ...
Posted by Michael Wonder on 10 Jul 2021
Frustrated cystic fibrosis patients await PBS subsidy to 'life changing' drug
9 July 2021 - In the days after Queensland mother Ella Sawyer gave birth, her baby daughter Evie didn't gain ...
Posted by Michael Wonder on 10 Jul 2021
Bayer’s Kerendia (finerenone) receives U.S. FDA approval for treatment of patients with chronic kidney disease associated with type 2 diabetes
9 July 2021 - First and only non-steroidal mineralocorticoid receptor antagonist approved for adults with chronic kidney disease associated with type ...
Posted by Michael Wonder on 10 Jul 2021
Application for cystic fibrosis medicine received by PHARMAC
9 July 2021 - PHARMAC is starting its funding assessment process for a new cystic fibrosis medication after receiving an ...
Posted by Michael Wonder on 09 Jul 2021
FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer
10 July 2021 - On 9 July 2021, the FDA approved enfortumab vedotin-ejfv (Padcev), for adult patients with locally advanced ...
Posted by Michael Wonder on 09 Jul 2021
ICER publishes evidence report on therapies for atopic dermatitis
9 July 2021 - Evidence demonstrates the JAK inhibitors abrocitinib and upadacitinib are effective treatments for atopic dermatitis, but safety concerns ...
Posted by Michael Wonder on 09 Jul 2021
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
9 July 2021 - EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases ...
Posted by Michael Wonder on 09 Jul 2021
Pfizer plans to request FDA approval for COVID booster shot in August
9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...
Posted by Michael Wonder on 08 Jul 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in oesophageal squamous cell carcinoma
7 July 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...