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 07 Oct 2022
FDA approves vaccine for use during third trimester of pregnancy to prevent whooping cough in infants younger than two months of age
7 October 2022 - Today, the US FDA approved Boostrix (Tetanus toxoid, reduced Diphtheria toxoid and acellular Pertussis vaccine, adsorbed) for ...
Posted by Michael Wonder on 07 Oct 2022
Hugel resubmits BLA for its botulinum toxin, Botulax to the US FDA
7 October 2022 - Hugel received CRL from the US FDA last March and completely supplemented documents and data. ...
Posted by Michael Wonder on 07 Oct 2022
Alnylam announces FDA approval of supplemental new drug application for Oxlumo (lumasiran) in advanced primary hyperoxaluria type 1
6 October 2022 - Approval is based on positive efficacy and safety results of the ILLUMINATE-C Phase 3 study of Oxlumo ...
Posted by Michael Wonder on 07 Oct 2022
Pembrolizumab in combination with platinum-based chemotherapy for treating recurrent, persistent or metastatic cervical cancer
5 October 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 07 Oct 2022
COVID-19 vaccine safety report (6 October 2022)
6 October 2022 - To 2 October 2022, the TGA has received 703 reports which have been assessed as likely to ...
Posted by Michael Wonder on 07 Oct 2022
COVID-19: nirmatrelvir/ritonavir reduces the risk of a severe course in patients at risk
4 October 2022 - However, due to contra-indications and interactions, the combination of active ingredients is not suitable for all patients ...
Posted by Michael Wonder on 07 Oct 2022
Desktop Health receives FDA clearance for SmileGuard resin for durable and comfortable orthodontic and dental appliances
6 October 2022 - Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth ...
Posted by Michael Wonder on 06 Oct 2022
Maribavir for treating refractory or resistant cytomegalovirus infection after transplant
28 September 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using maribavir ...
Posted by Michael Wonder on 06 Oct 2022
Palbociclib combination in advanced breast cancer: again only disadvantages
5 October 2022 - For post-menopausal women with hormone receptor positive, HER2 negative breast cancer in the first line, there is ...
Posted by Michael Wonder on 06 Oct 2022
Santen announces Health Canada approval for Cationorm Plus to relieve the symptoms of dry eye and ocular allergy
6 October 2022 - Santen Canada today announced the approval of Cationorm Plus by Health Canada. ...
Posted by Michael Wonder on 06 Oct 2022
Lilly receives US FDA fast track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related co-morbidities
6 October 2022 - The fast track designation accelerates tirzepatide's path to US FDA submission for the treatment of adults ...
Posted by Michael Wonder on 06 Oct 2022
Polatuzumab vedotin in combination for untreated diffuse large B-cell lymphoma
28 September 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 06 Oct 2022
HHS implements inflationary rebates for list prices of Medicare Part D (outpatient) drugs
5 October 2022 - On 1 October, the Department of Health and Human Services began implementing one of three main prescription ...
Posted by Michael Wonder on 06 Oct 2022
US FDA accepts Takeda’s supplemental biologics license application for use of Takzyro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
5 October 2022 - Filing is based on data from Phase 3 SPRING study in paediatric patients 2 to <12 years ...