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 26 Oct 2023
Paying for it: how health care costs and medical debt are making Americans sicker and poorer
26 October 2023 - Findings from the Commonwealth Fund 2023 Health Care Affordability Survey. ...
Posted by Michael Wonder on 26 Oct 2023
FDA accepts ImmunityBio’s BLA resubmission as complete and sets new PDUFA date
26 October 2023 - A new PDUFA date of 23 April 2024 has been communicated by the Agency. ...
Posted by Michael Wonder on 26 Oct 2023
US FDA grants Paige breakthrough device designation for cancer detection in breast lymph nodes
26 October 2023 - Paige announced today that the US FDA has granted breakthrough device designation for Paige Lymph Node, an ...
Posted by Michael Wonder on 26 Oct 2023
Olipudase alfa for the treatment of patients with acid sphingomyelinase deficiency (Niemann-Pick disease type B and AB)
26 October 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 26 Oct 2023
First NICE recommended treatment for Parkinson’s set to benefit hundreds
26 October 2023 - Around 900 adults with advanced Parkinson’s are set to benefit from new treatment foslevodopa–foscarbidopa after NICE approved ...
Posted by Michael Wonder on 26 Oct 2023
ViiV Healthcare receives approval from China’s National Medical Products Administration for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment
26 October 2023 - The marketing authorisation for rilpivirine long-acting injection was received on the 18 October 2023. ...
Posted by Michael Wonder on 26 Oct 2023
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) is available for the first-line treatment of adult patients with advanced or metastatic renal cell carcinoma
25 October 2023 - Merck and Eisai announced today that Keytruda, an anti-PD-1 therapy, in combination with Lenvima, the multiple receptor ...
Posted by Michael Wonder on 26 Oct 2023
Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
Posted by Michael Wonder on 25 Oct 2023
Akebia receives FDA acceptance of resubmission to NDA of vadadustat for the treatment of anaemia due to chronic kidney disease
25 October 2023 - 27 March 2024 set as user fee goal date. ...
Posted by Michael Wonder on 25 Oct 2023
At $550/month, new menopause hot flash drug may be out of reach for many women
24 October 2023 - Heralded as the first and only treatment thus far to block a source of hot flashes in ...
Posted by Michael Wonder on 25 Oct 2023
Baricitinib for the treatment of patients with severe alopecia areata (update)
25 October 2023 - NICE has published final evidence-based recommendations on the use of baricitinib (Olumiant) for the treatment of ...
Posted by Michael Wonder on 25 Oct 2023
Mirikizumab for the treatment of patients with moderate to severe active ulcerative colitis
25 October 2023 - NICE has published final evidence-based recommendations on the use of mirikizumab (Omvoh) for the treatment of ...
Posted by Michael Wonder on 25 Oct 2023
Tirzepatide for the treatment of patients with type 2 diabetes mellitus
25 October 2023 - NICE has published final evidence-based recommendations on the use of tirzepatide (Mounjaro) for the treatment of ...
Posted by Michael Wonder on 25 Oct 2023
Daratumumab in combination with lenalidomide and dexamethasone for untreated patients with multiple myeloma who are ineligible for stem cell transplantation
25 October 2023 - NICE has published final evidence-based recommendations on the use of daratumumab (Darzalex) in combination with lenalidomide ...
Posted by Michael Wonder on 25 Oct 2023
Orphelia Pharma files EU marketing authorisation application for Kizfizo
24 October 2023 - Orphelia Pharma today announces the filing of a centralised marketing authorisation application to the EMA for ...