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 21 Jan 2022
U.S. FDA approves second indication for Skyrizi (risankizumab-rzaa) to treat adults with active psoriatic arthritis
21 January 2022 - Skyrizi (risankizumab-rzaa) met the primary endpoint of ACR20 at week 24 in two pivotal studies, demonstrating significant ...
Posted by Michael Wonder on 21 Jan 2022
Japan’s MHLW approves Pfizer and OPKO’s Ngenla (somatrogon), a new long-acting treatment for paediatric growth hormone deficiency
20 January 2022 - Ngenla offers a new once weekly treatment option for children living with growth hormone deficiency. ...
Posted by Michael Wonder on 21 Jan 2022
National Medicines Policy Review – publication of submissions
21 January 2022 - On 30 August 2021, the National Medicines Policy Review Committee invited submissions to support the Review of ...
Posted by Michael Wonder on 20 Jan 2022
Jyseleca (filgotinib) licensed for the treatment of adult patients with moderately to severely active ulcerative colitis in Great Britain
18 January 2022 - Galapagos announced today that the Medicines and Healthcare products Regulatory Agency has granted a marketing authorization ...
Posted by Michael Wonder on 20 Jan 2022
The G-BA classifies three drugs as reserve antibiotics
20 January 2022 - The Federal Joint Committee (G-BA) today exempted three drugs classified as reserve antibiotics from the regular early ...
Posted by Michael Wonder on 20 Jan 2022
Immunotherapy with blinatumomab improves the chances of survival in very rare childhood blood cancer
20 January 2022 - The Federal Joint Committee (G-BA) today classified the additional benefit of the active ingredient blinatumomab as significant ...
Posted by Michael Wonder on 20 Jan 2022
Lumakras (sotorasib) receives approval in Japan for patients with KRAS G12C mutated advanced non-small cell lung cancer
20 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumakras. ...
Posted by Michael Wonder on 20 Jan 2022
Bristol Myers Squibb receives approval for Abecma (idecabtagene vicleucel), the first CAR T therapy approved for the treatment of multiple myeloma in Japan
20 January 2022 - Bristol-Myers Squibb today announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene ...
Posted by Michael Wonder on 20 Jan 2022
Billionaire Mark Cuban opens online pharmacy to provide affordable generic drugs
20 January 2022 - Billionaire investor Mark Cuban launched an online pharmacy Thursday that offers more than 100 generic drugs at ...
Posted by Michael Wonder on 20 Jan 2022
COVID-19 vaccine weekly safety report (20 January 2022)
20 January 2022 - To 16 January 2022, the TGA has received 428 reports which have been assessed as likely to ...
Posted by Michael Wonder on 20 Jan 2022
NICE moves: increased accessibility and flexibility for health tech
19 January 2022 - NICE also aims to make strides in digital, genomic and antimicrobial technologies ...
Posted by Michael Wonder on 20 Jan 2022
NICE signals commitment to greater flexibility in its evaluation of promising new health technologies and making patient access fairer
20 January 2022 - Changes to the way medicines and other health technologies are evaluated by NICE for use in the ...
Posted by Michael Wonder on 20 Jan 2022
Statement on the arrival of the Novavax vaccine and COVID-19 pills
20 January 2022 - Medicines Australia welcomes the TGA’s provisional approval for the Novavax COVID-19 vaccine and the provisional approval ...
Posted by Michael Wonder on 20 Jan 2022
Omeros confirms submission of response to FDA regarding the BLA for narsoplimab in the treatment of HSCT-TMA
19 January 2022 - Omeros Corporation today confirmed that earlier this month the company submitted to the U.S. FDA its response ...
Posted by Michael Wonder on 20 Jan 2022
Pathogenomix granted FDA breakthrough device designation
19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...