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 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...
Posted by Michael Wonder on 24 May 2022
United Therapeutics announces FDA approval of Tyvaso DPI
24 May 2022 - First approval of a dry powder inhaler for treatment of pulmonary arterial hypertension and pulmonary hypertension associated with ...
Posted by Michael Wonder on 24 May 2022
FDA grants breakthrough device designation to Anumana’s ECG pulmonary hypertension early detection AI algorithm
24 May 2022 - Anumana today announced that the U.S. FDA has granted breakthrough device designation to its AI-enhanced, ECG based ...
Posted by Michael Wonder on 24 May 2022
FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
Posted by Michael Wonder on 24 May 2022
Budget 2022: PHARMAC funding boost a 'glimpse of hope' for cystic fibrosis sufferer
25 May 2022 - For the first time in his life, Troy Watson thought he was going to "lose the ...
Posted by Michael Wonder on 24 May 2022
Neuronascent receives FDA rare paediatric drug designation for NNI-351 treatment for Fragile X syndrome
24 May 2022 - Neuronascent today announced that the US FDA granted rare paediatric designation for NNI-351 for Fragile X ...
Posted by Michael Wonder on 24 May 2022
Avacopan for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis
24 May 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 24 May 2022
FDA approves Dermavant’s Vtama (tapinarof) 1% cream for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the U.S. in 25 years
23 May 2022 - In the pivotal Phase 3 clinical trial program, Vtama cream met all primary and secondary endpoints and ...
Posted by Michael Wonder on 24 May 2022
ImmunityBio submits biologics license application for N-803 plus BCG for patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 May 2022 - Results for this FDA designated breakthrough therapy exceed historical complete response rates and duration of response ...
Posted by Michael Wonder on 24 May 2022
ImmunoGen announces acceptance of biologics license application for mirvetuximab soravtansine in ovarian cancer by US Food and Drug Administration with priority review
23 May 2022 - PDUFA date is 28 November 2022. ...
Posted by Michael Wonder on 24 May 2022
Nymox receives RTF letter from FDA
23 May 2022 - Nymox Pharmaceutical Corporation reports today that it has received a refusal to file letter from FDA ...
Posted by Michael Wonder on 24 May 2022
Medicines Australia ready to work with new Government on medicines reform and life sciences
23 May 2022 - Medicines Australia congratulates Anthony Albanese and the Labor Party on their election win and forming Government. ...
Posted by Michael Wonder on 24 May 2022
COVID-19 anti-viral access criteria assessment tool
24 May 2022 - PHARMAC has released an online tool to help clinicians identify who’s eligible for funded COVID-19 anti-viral ...
Posted by Michael Wonder on 23 May 2022
Draft CADTH recommendation for Spinraza (nusinersen sodium) fails adults in need of treatment for spinal muscular atrophy
20 May 2022 - CADTH does not accept new evidence demonstrating Spinraza's effectiveness and safety for treating spinal muscular atrophy – ...
Posted by Michael Wonder on 23 May 2022
US FDA accepts for review Biohaven's new drug application filing of intranasal zavegepant for the acute treatment of migraine
23 May 2022 - If approved, zavegepant nasal spray would be the only FDA approved calcitonin gene related peptide receptor antagonist ...