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 25 Aug 2021
Ascendis Pharma announces U.S. FDA approval of Skytrofa (lonapegsomatropin-tcgd), the first once weekly treatment for paediatric growth hormone deficiency
25 August 2021 - Availability in the U.S. expected shortly supported by a full suite of patient support programs. ...
Posted by Michael Wonder on 25 Aug 2021
Ono and Takeda receive an approval for Opdivo (nivolumab) and Cabometyx (cabozantinib) combination therapy in Japan for treatment of unresectable or metastatic renal cell carcinoma
25 August 2021 - Ono Pharmaceutical and Takeda today announced that the companies have received an approval for combination therapy of ...
Posted by Michael Wonder on 25 Aug 2021
ICER to assess novel agents to prevent chemotherapy-induced neutropenia
25 August 2021 - Report will be subject of CTAF meeting in April 2022; draft scoping document open to public comment ...
Posted by Michael Wonder on 25 Aug 2021
NICE publishes appraisal guidance on new medicine for patients with biliary tract cancer
25 August 2021 - Pemigatinib (Pemaryze, Incyte) has a conditional marketing authorisation for the treatment of adults with locally advanced or ...
Posted by Michael Wonder on 25 Aug 2021
FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukaemia
25 August 2021 - Novartis today announced that the US FDA accepted and granted priority review to the company’s new drug ...
Posted by Michael Wonder on 25 Aug 2021
FDA label updates reflect Bayer’s commitment to women’s healthcare
25 August 2021 - FDA approves extension of intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg for up to seven years ...
Posted by Michael Wonder on 25 Aug 2021
Avastin biosimilar may bring insurance benefits for Tecentriq
25 August 2021 - The government has been delaying discussing whether to allow reimbursement for Tecentriq (atezolizumab) due to concerns ...
Posted by Michael Wonder on 25 Aug 2021
Health Canada grants marketing authorisation for Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
24 August 2021 - Minjuvi is a new therapeutic option for eligible patients with DLBCL in Canada to address an ...
Posted by Michael Wonder on 25 Aug 2021
Stealth BioTherapeutics submits elamipretide new drug application to FDA for treatment of Barth syndrome
24 August 2021 - Stealth BioTherapeutics today announced the submission of a new drug application to the U.S. FDA for elamipretide, ...
Posted by Michael Wonder on 24 Aug 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in nasopharyngeal cancer
22 August 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...
Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
Posted by Michael Wonder on 24 Aug 2021
Humanetics Corporation’s BIO 300 receives fast track designation from FDA
24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...
Posted by Michael Wonder on 24 Aug 2021
ICER uses observational real world evidence to update 2018 assessment on therapies for hereditary angioedema, finds therapies far less cost effective than earlier estimates
24 August 2021 - Patients initiating therapy in real world dataset had less frequent baseline attack rates than rates from clinical ...
Posted by Michael Wonder on 24 Aug 2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech/Pfizer and Moderna
24 August 2021 - EMA’s CHMP has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the ...
Posted by Michael Wonder on 24 Aug 2021
FDA approves expanded peripheral artery disease indication for Xarelto (rivaroxaban) plus aspirin to include patients after lower extremity revascularisation due to symptomatic peripheral artery disease
24 August 2021 - Xarelto is the first and only therapy indicated for both coronary artery disease and peripheral artery disease, ...