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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 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 28 Mar 2023
iOnctura awarded UK's MHRA Innovation Passport for entry into innovative licensing and access pathway
28 March 2023 - iOnctura today announces that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, ...
Posted by Michael Wonder on 28 Mar 2023
Ono receives supplemental approval of Opdivo in combination with chemotherapy for neo-adjuvant treatment of non-small-cell lung cancer in Japan
27 March 2023 - Ono Pharmaceutical and Bristol-Myers Squibb today announced that Ono Pharmaceutical has received a supplemental approval of ...
Posted by Michael Wonder on 28 Mar 2023
Amicus Therapeutics announces European Commission approval for Pombiliti in patients with late-onset Pompe disease
27 March 2023 - CHMP opinion for miglustat, the oral enzyme stabiliser component of AT-GAA, on track for 2Q, 2023. ...
Posted by Michael Wonder on 27 Mar 2023
Incyte announces Japanese approval of Pemazyre (pemigatinib) for the treatment of patients with myeloid/lymphoid neoplasms
27 March 2023 - Incyte today announced that the Japanese Ministry of Health, Labour and Welfare has approved Pemazyre (pemigatinib), a ...
Posted by Michael Wonder on 27 Mar 2023
Finerenone for the treatment of chronic kidney disease in patients with type 2 diabetes
23 March 2023 - NICE has issued evidence-based recommendations on the use of finerenone (Kerendia) for the treatment of adults ...
Posted by Michael Wonder on 27 Mar 2023
Clinical trial considerations to support accelerated approval of oncology therapeutics
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
Posted by Michael Wonder on 27 Mar 2023
Final reconciliation of savings from side agreements for the full year 2022
28 March 2023 - The TLV has presented the Government with the final reconciliation of the outcome of savings from ...
Posted by Michael Wonder on 27 Mar 2023
Delcath Systems announces FDA acceptance of new drug application resubmission of Hepzato Kit with a PDUFA date of 14 August 2023
27 March 2023 - Delcath Systems announced that the US FDA has accepted Delcath Systems' new drug application resubmission for Hepzato ...
Posted by Michael Wonder on 27 Mar 2023
Enhertu approved in Japan as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
27 March 2023 - Approval based on DESTINY-Breast04 results showing Enhertu reduced the risk of disease progression or death by ...
Posted by Michael Wonder on 27 Mar 2023
Iovance Biotherapeutics completes biologics license application submission for lifileucel in advanced melanoma
24 March 2023 - First TIL therapy BLA submission to US FDA. ...
Posted by Michael Wonder on 27 Mar 2023
Kite's Yescarta (axicabtagene ciloleucel) first CAR T-cell therapy to receive Health Canada authorisation for use in second-line large B-cell lymphoma
23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...
Posted by Michael Wonder on 27 Mar 2023
EMA validates marketing authorisation application for Henlius' Hansizhuang (serplulimab)
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...
Posted by Michael Wonder on 27 Mar 2023
FDA outlines plan for digital health technologies for clinical trials
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
Posted by Michael Wonder on 27 Mar 2023
Biden says he wants to bring down drug prices. His actions tell a different story.
24 March 2023 - You might get the impression from the Biden administration’s insulin price cut and its initiative allowing ...