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 May 2022
Perverse incentives - HIV prevention and the 340B drug pricing program
28 May 2022 - A decade after preexposure prophylaxis against HIV became available, less than a quarter of people in the ...
Posted by Michael Wonder on 29 May 2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...
Posted by Michael Wonder on 28 May 2022
Amneal achieves third U.S. biosimilar approval with Fylnetra (pegfilgrastim-pbbk)
27 May 2022 - Marks Amneal’s third biosimilar approval in 2022. ...
Posted by Michael Wonder on 28 May 2022
Where is the PHARMAC review?
28 May 2022 - “It has been three months to the day since the Minister received the PHARMAC review, why ...
Posted by Michael Wonder on 28 May 2022
U.S. FDA declines to approve Eton Pharma's anti-seizure drug
27 May 2022 - Eton Pharmaceuticals said on Friday the U.S. FDA declined to approve its anti-seizure drug lamotrigine. ...
Posted by Michael Wonder on 28 May 2022
U.S. Food and Drug Administration approves two Opdivo (nivolumab) based regimens as first-line treatments for unresectable advanced or metastatic oesophageal squamous cell carcinoma
27 May 2022 - Opdivo in combination with chemotherapy and Opdivo plus Yervoy (ipilimumab) approved based on a Phase 3 trial ...
Posted by Michael Wonder on 28 May 2022
FDA approves Novartis Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma
27 May 2022 - 68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response ...
Posted by Michael Wonder on 27 May 2022
Medicare premium increase from Alzheimer’s drug to be lowered next year
27 May 2022 - Health and Human Services Secretary Xavier Becerra announced on Friday that Medicare premiums would be adjusted ...
Posted by Michael Wonder on 27 May 2022
Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
27 May 2022 - The Senate is taking pains to avoid another Aduhelm controversy. ...
Posted by Michael Wonder on 27 May 2022
Carvykti (ciltacabtagene autoleucel) granted conditional approval by the European Commission for the treatment of patients with relapsed and refractory multiple myeloma
26 May 2022 - The approval is based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 27 May 2022
Biden has confidence in the FDA and its commissioner, White House says
27 May 2022 - U.S. President Joe Biden has confidence in the U.S. FDA and its commissioner Robert Califf, White House ...
Posted by Michael Wonder on 27 May 2022
FDA grants breakthrough device designation for Emily's Care Nourish Test System
26 May 2022 - Lactation Lab has announced today that the U.S. FDA, has granted the company breakthrough device designation ...
Posted by Michael Wonder on 26 May 2022
From scientific discovery to covered treatments: understanding the payer perspective as a keystone to achieving high value care
26 May 2022 - The mission of the National Institutes of Health is to translate scientific discovery into health by designing ...
Posted by Michael Wonder on 26 May 2022
Perrigo announces U.S. FDA approval for omeprazole magnesium delayed release mini capsules
26 May 2022 - Perrigo today announced that it has received final approval from the U.S. FDA for omeprazole magnesium delayed ...
Posted by Michael Wonder on 26 May 2022
Revolutionary wearable ultrasound device gains FDA approval
26 May 2022 - ManaMed has been granted FDA approval on its latest orthopaedic recovery device, ManaSport. ...