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RSS FeedPosted by Michael Wonder on 23 Mar 2023
FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
22 March 2023 - Today the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte) for adult patients with metastatic or ...
Posted by Michael Wonder on 23 Mar 2023
AbbVie provides regulatory update on ABBV-951 (foscarbidopa/foslevodopa) new drug application
22 March 2023 - AbbVie today announced it received a complete response letter from the US FDA for the new ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 22 Mar 2023
FDA approves first in class Evkeeza (evinacumab-dgnb) for young children with ultra rare form of high cholesterol
22 March 2023 - Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolaemia, an inherited condition characterised ...
Posted by Michael Wonder on 22 Mar 2023
Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access
20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...
Posted by Michael Wonder on 22 Mar 2023
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
Posted by Michael Wonder on 22 Mar 2023
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 March 2023 - Biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation approved for seven indications of reference medicine Humira. ...
Posted by Michael Wonder on 22 Mar 2023
Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes
20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...
Posted by Michael Wonder on 21 Mar 2023
Top FDA official: agency needs to start using accelerated approval for gene therapies
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
Posted by Michael Wonder on 21 Mar 2023
Prestige Biopharma receives FDA fast track designation for PBP1510 in the treatment of pancreatic cancer
21 March 2023 - Prestige Biopharma has received fast track designation from the US FDA for PBP1510 (ulenistamab), in the ...
Posted by Michael Wonder on 20 Mar 2023
Opioid settlement hinders patients’ access to a wide array of drugs
13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...
Posted by Michael Wonder on 20 Mar 2023
Arrowhead receives FDA fast track designation for ARO-APOC3
20 March 2023 - Arrowhead Pharmaceuticals today announced the US FDA has granted fast track designation to ARO-APOC3 for reducing ...
Posted by Michael Wonder on 19 Mar 2023
Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18
14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating ...
Posted by Michael Wonder on 19 Mar 2023
Prestige Biopharma's pancreatic cancer drug candidate put on FDA fast track
17 March 2023 - Prestige Biopharma said on Thursday that its new pancreatic cancer antibody drug candidate, PBP1510, (ulenistamab), was ...
Posted by Michael Wonder on 17 Mar 2023
FDA approves dabrafenib with trametinib for paediatric patients with low grade glioma with a BRAF V600E mutation
16 March 2023 - Today, the FDA approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for paediatric patients 1 year ...