Blog
RSS FeedPosted by Michael Wonder on 18 May 2024
FDA withdraws accelerated approval to infigratinib for metastatic cholangiocarcinoma
16 May 2024 - Today, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, ...
Posted by Michael Wonder on 17 May 2024
HLB shares plummet following FDA rejection of liver cancer drug approval
17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...
Posted by Michael Wonder on 16 May 2024
Nuvalent receives US FDA breakthrough therapy designation for NVL-655
16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the ...
Posted by Michael Wonder on 16 May 2024
As childhood asthma worsens, insurers restrict access to an essential medication
16 May 2024 - As paediatricians who take care of children in the inpatient, emergency, and primary care settings, we ...
Posted by Michael Wonder on 16 May 2024
FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer
16 May 2024 - Today, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive stage small cell lung ...
Posted by Michael Wonder on 16 May 2024
Axogen initiates rolling submission of biologics license application to US FDA for Avance Nerve Graft
16 May 2024 - Axogen is pleased to announce that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 15 May 2024
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 15 May 2024
Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...
Posted by Michael Wonder on 15 May 2024
Eisai initiates rolling biologics license application to US FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing
15 May 2024 - BioArctic's partner Eisai announced today that they have initiated the rolling submission of a biologics license application ...
Posted by Michael Wonder on 15 May 2024
PTC Therapeutics announces FDA acceptance and priority review of the BLA for Upstaza
14 May 2024 - PDUFA target action date of 13 November 2024. ...
Posted by Michael Wonder on 14 May 2024
Baxter secures FDA approval of Clinolipid (lipid injectable emulsion) neonatal and paediatric indication
13 May 2024 - Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates ...
Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...
Posted by Michael Wonder on 14 May 2024
Sumitomo Pharma announces FDA acceptance of supplemental new drug application for vibegron in men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia
13 May 2024 - Supplemental new drug application submission based on Phase 3 study of vibegron 75 mg (Gemtesa) demonstrating statistically ...
Posted by Michael Wonder on 13 May 2024
Petosemtamab granted breakthrough therapy designation by the US FDA
13 May 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for petosemtamab for the ...