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 29 Sep 2021
Selux Diagnostics earns FDA breakthrough device designation for next generation phenotyping platform for positive blood culture and sterile body fluid samples
28 September 2021 - Selux next generation phenotyping now qualifies for expedited FDA review process as single-platform technology for rapid antimicrobial ...
Posted by Michael Wonder on 29 Sep 2021
Novian Health gains FDA breakthrough designation for Novilase breast therapy
28 September 2021 - Novian Health has been granted breakthrough device designation from the U.S. FDA for its Novilase Interstitial Laser ...
Posted by Michael Wonder on 29 Sep 2021
FDA approves Qulipta (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine
27 September 2021 - Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days among adults ...
Posted by Michael Wonder on 29 Sep 2021
FDA expands Lilly's Erbitux (cetuximab) label with combination of Braftovi (encorafenib) for the treatment of BRAF V600E mutation positive metastatic colorectal cancer after prior therapy
28 September 2021 - Erbitux is the first and only anti-EGFR antibody approved, in combination with encorafenib, specifically for adults ...
Posted by Michael Wonder on 28 Sep 2021
Onpattro (patisiran) now reimbursed in Canada for the treatment of hereditary transthyretin mediated amyloidosis
28 September 2021 - Onpattro is the only treatment that has demonstrated improvement in both polyneuropathy and quality of life ...
Posted by Michael Wonder on 28 Sep 2021
Pfizer and BionNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
28 September 2021 - Formal submission to request Emergency Use Authorization to follow in the coming weeks. ...
Posted by Michael Wonder on 28 Sep 2021
TGA grants provisional determination to Roche COVID-19 treatment tocilizumab (Actemra)
28 September 2021 - On 27 September 2021, the TGA granted provisional determination to Roche in relation to the COVID-19 ...
Posted by Michael Wonder on 28 Sep 2021
Lipocine announces FDA affirmation of Class 1 NDA resubmission for Tlando
28 September 2021 - Lipocine today announced the U.S. FDA has affirmed the resubmission of its new drug application for Tlando, ...
Posted by Michael Wonder on 28 Sep 2021
People share their stories: the human cost of high prescription drug prices
28 September 2021 - Why AARP keeps fighting to get your medication expenses under control. ...
Posted by Michael Wonder on 28 Sep 2021
Valuing SF-6Dv2 in Australia using an international protocol
28 September 2021 - The SF-6Dv2 is an updated version of the SF-6D, with improved consistency and dimension descriptors, and value ...
Posted by Michael Wonder on 28 Sep 2021
Big business lobbies bitterly divided over drug pricing reform
28 September 2021 - Groups representing companies like Apple, Tesla, and Boeing are clashing with Washington’s wealthiest business lobby over ...
Posted by Michael Wonder on 28 Sep 2021
A review of utility measurement methods used in pharmacoeconomic submissions to HIRA in South Korea: methodological consistency and areas for improvement
28 September 2021 - This study, which was conducted as part of a project for revision of the pharmacoeconomic ...
Posted by Michael Wonder on 28 Sep 2021
FDA grants priority review to ViiV Healthcare’s new drug application for cabotegravir long-acting for prevention of HIV
28 September 2021 - Final FDA decision anticipated by 24 January 2022; if approved, cabotegravir would be the first long-acting ...
Posted by Michael Wonder on 28 Sep 2021
FDA accepts Libtayo (cemiplimab-rwlc) for priority review for advanced cervical cancer
28 September 2021 - European Union regulatory submission planned by end of 2021. ...
Posted by Michael Wonder on 28 Sep 2021
Lilly again reduces list price of insulin lispro Injection as latest change to affordability options
28 September 2021 - Lilly's insulin lispro injection -- first introduced at half the list price of branded Humalog in 2019 ...