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 Apr 2022
COVID-19 vaccine weekly safety report (7 April 2022)
7 April 2022 - To 3 April 2022, the TGA has received 511 reports which have been assessed as likely to ...
Posted by Michael Wonder on 07 Apr 2022
TGA approves yet another new medicine for patients with psoriasis
7 April 2022 - Bimekizumab is a humanised immunoglobulin G1 kappa monoclonal antibody. It has two identical antigen binding regions that ...
Posted by Michael Wonder on 07 Apr 2022
Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation
7 April 2022 - Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung ...
Posted by Michael Wonder on 07 Apr 2022
BeiGene announces European Medicines Agency acceptance of marketing authorisation applications for tislelizumab for the treatment of patients with ESCC and NSCLC
6 April 2022 - First European submissions for BeiGene’s anti PD-1 antibody licensed to Novartis for North America, Europe and ...
Posted by Michael Wonder on 06 Apr 2022
Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.
6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...
Posted by Michael Wonder on 06 Apr 2022
Eligible individuals can receive second COVID-19 booster shot at no cost
6 April 2022 - Today, the Centers for Medicare & Medicaid Services announced it will pay for a second COVID-19 booster ...
Posted by Michael Wonder on 06 Apr 2022
Inside a campaign to get Medicare coverage for a new Alzheimer’s drug
6 April 2022 - The Alzheimer’s Association has pushed relentlessly to get broad access to Aduhelm, despite safety risks and ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 06 Apr 2022
BioXcel Therapeutics announces FDA approval of Igalmi (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults
6 April 2022 - U.S. commercial launch planned for Q2 2022. ...
Posted by Michael Wonder on 06 Apr 2022
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
6 April 2022 - The European Centre for Disease Prevention and Control and EMA’s COVID-19 task force have concluded that ...
Posted by Michael Wonder on 06 Apr 2022
Dialectic Therapeutics announces DT2216 has received fast track designation from the FDA for adult patients with relapsed or refractory peripheral and cutaneous T-cell lymphoma
5 April 2022 - Dialectic Therapeutics today announced that the U.S. FDA has granted fast track designation to DT2216 for adult ...
Posted by Michael Wonder on 06 Apr 2022
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) with chemotherapy as first-line treatment for patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
5 April 2022 - Opdivo with chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy alone ...
Posted by Michael Wonder on 06 Apr 2022
FDA approves Novartis Vijoice (alpelisib) as first and only treatment for select patients with PIK3CA related overgrowth spectrum
6 April 2022 - Approval based on real world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction ...
Posted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
5 April 2022 - Opdivo plus Yervoy is one of two newly approved Opdivo based treatment regimens to demonstrate superior overall ...
Posted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for certain forms of relapsed or refractory large B-cell lymphoma
5 April 2022 - Approval of Breyanzi is based on results from TRANSCEND WORLD, and TRANSCEND NHL 001, the largest pivotal ...