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RSS FeedPosted by Michael Wonder on 27 May 2024
EMA publishes agenda for 27-30 May 2024 CHMP meeting
27 May 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 May 2024
FDA Advisory Committee Panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option
23 May 2024 - Shield remains on track to become the first FDA approved blood test that meets performance requirements for ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...
Posted by Michael Wonder on 25 May 2024
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...
Posted by Michael Wonder on 25 May 2024
Verastem Oncology announces the initiation of a rolling submission of NDA to FDA seeking accelerated approval of avutometinib and defactinib combination for the treatment of adult patients with recurrent KRAS mutant low grade serous ovarian cancer
24 May 2024 - Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of ...
Posted by Michael Wonder on 25 May 2024
Sobi receives US FDA fast track designation for emapalumab-lzsg being investigated in macrophage activation syndrome
24 May 2024 - Sobi North America today announced that the US FDA has granted fast track designation to emapalumab-lzsg being ...
Posted by Michael Wonder on 24 May 2024
Camurus receives EMA acceptance of MAA filing for octreotide SC depot (CAM2029) for the treatment of acromegaly
23 May 2024 - Camurus today announced that the EMA has accepted for review the company’s marketing authorisation application for octreotide ...
Posted by Michael Wonder on 23 May 2024
Jiangsu to ‘reapply for US approval of rivoceranib combo therapy ASAP’
23 May 2024 - Hangseo Hengrui Pharmaceuticals said Thursday that it would meet with the US FDA as soon as ...
Posted by Michael Wonder on 23 May 2024
Theriva Biologics announces fast track designation granted by the US FDA for VCN-01 for the treatment of metastatic pancreatic cancer
23 May 2024 - Theriva Biologics today announced that the US FDA has granted fast track designation to lead clinical candidate ...
Posted by Michael Wonder on 23 May 2024
COTA announces extended collaboration with FDA to advance the use of real world data in cancer research
22 May 2024 - Today, COTA announced an extension of its research collaboration with the US FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 23 May 2024
Cartesian Therapeutics receives FDA regenerative medicine advanced therapy designation for Descartes-08 for the treatment of myasthenia gravis
22 May 2024 - Cartesian Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation for ...
Posted by Michael Wonder on 23 May 2024
Pfizer announces availability of Abrysvo in Canada for immunisation of pregnant individuals and adults 60+
22 May 2024 - Availability of Arbysvo is a major step in protecting infants and adults 60 years of age ...
Posted by Michael Wonder on 23 May 2024
Health Canada approves Cosentyx, a biologic therapy, for the treatment of adults with moderate to severe hidradenitis suppurativa
22 May 2024 - Approval is based on the two largest Phase 3 trials conducted in hidradenitis suppurativa – SUNSHINE and SUNRISE ...
Posted by Michael Wonder on 22 May 2024
Roche granted FDA breakthrough device designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk
22 May 2024 - The test has been developed in collaboration with Amgen. ...
Posted by Michael Wonder on 22 May 2024
Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe
22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...