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 22 Jun 2022
MSAC publishes agenda for October 2022 ESC meeting
22 June 2022 - The MSAC Secretariat has published a list of applications scheduled to be considered by the ESC on ...
Posted by Michael Wonder on 22 Jun 2022
New $11 million winter vaccine communication campaign and availability of antivirals
22 June 2022 - The Australian Government today launched an $11 million six-week campaign to encourage people to get vaccinated for ...
Posted by Michael Wonder on 22 Jun 2022
U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children
22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...
Posted by Michael Wonder on 22 Jun 2022
Krystal Biotech submits biologics license application to U.S. FDA seeking approval of B-VEC for the treatment of patients with dystrophic epidermolysis bullosa
22 June 2022 - Krystal Biotech announced today the submission of a biologics license application to the U.S. FDA seeking ...
Posted by Michael Wonder on 22 Jun 2022
Ikena Oncology receives FDA fast track designation for novel TEAD inhibitor IK-930 to treat unresectable NF2 deficient mesothelioma
22 June 2022 - Ikena Oncology today announced that the U.S. FDA has granted fast track designation for IK-930, the Company’s ...
Posted by Michael Wonder on 22 Jun 2022
BioMarin announces the Ministry of Health, Labor and Welfare in Japan granted approval for Voxzogo (vosoritide) for injection for the treatment of children with achondroplasia, whose growth plates are not closed
21 June 2022 - No lower age restriction for treatment. ...
Posted by Michael Wonder on 22 Jun 2022
FDA grants breakthrough device designation to VR mental illness treatment
22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...
Posted by Michael Wonder on 22 Jun 2022
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
Posted by Michael Wonder on 21 Jun 2022
Paratek Pharmaceuticals’ Nuzyra receives FDA fast track designation for the treatment of pulmonary non-tuberculous mycobacterial disease caused by mycobacterium avium complex and mycobacterium abscessus
21 June 2022 - Phase 2b study in MAB pulmonary infections on-going and enrolling as planned. ...
Posted by Michael Wonder on 21 Jun 2022
EQRx announces acceptance of marketing authorisation application by the UK's Medicines and Healthcare Products Regulatory Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
14 June 2022 - Application is based on data from pivotal Phase 3 AENEAS trial in the first-line treatment of EGFR ...
Posted by Michael Wonder on 21 Jun 2022
Medicare could’ve saved $3.6 billion by buying drugs at same prices as Mark Cuban’s online pharmacy, according to a new study
22 June 2022 - Medicare’s drug program could have saved up to $3.6 billion in 2020 by mirroring the pricing ...
Posted by Michael Wonder on 21 Jun 2022
AbbVie submits supplemental new drug application to U.S. FDA for atogepant (Qulipta) to support label expansion for the preventive treatment of migraine
21 June 2022 - Submission is based on pivotal Phase 3 PROGRESS chronic migraine study evaluating atogepant (Qulipta) in adult patients ...
Posted by Michael Wonder on 21 Jun 2022
Acer Therapeutics and Relief Therapeutics announce update on U.S. FDA review of new drug application for ACER-001
21 June 2022 - Citing the need to inspect a third-party contract packaging manufacturer, the U.S. FDA has issued a complete ...
Posted by Michael Wonder on 21 Jun 2022
Tebentafusp for treating advanced (unresectable or metastatic) uveal melanoma
21 June 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using tebentafusp ...
Posted by Michael Wonder on 21 Jun 2022
European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...