Blog
RSS FeedPosted by Michael Wonder on 01 Oct 2024
Enhertu granted priority review in the US for patients with HER2 low or HER2 ultra-low metastatic breast cancer who have received at least one line of endocrine therapy
1 October 2024 - Based on DESTINY-Breast06 phase 3 trial which demonstrated a statistically significant and clinically meaningful progression-free survival ...
Posted by Michael Wonder on 30 Sep 2024
Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)
30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has ...
Posted by Michael Wonder on 30 Sep 2024
FDA approves imaging drug for evaluation of myocardial ischaemia and infarction
27 September 2024 - The US FDA has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary ...
Posted by Michael Wonder on 29 Sep 2024
Enterprise Therapeutics granted rare paediatric disease designation in the US for novel cystic fibrosis investigational therapy ETD001
26 September 2024 - ETD001 is a novel, first in class blocker of the epithelial sodium channel aimed at treating people ...
Posted by Michael Wonder on 29 Sep 2024
Dupixent (dupilumab) approved in the US as the first ever biologic medicine for patients with COPD
27 September 2024 - Following recent approvals in the EU and China, the US approval is based on two landmark Phase ...
Posted by Michael Wonder on 29 Sep 2024
FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer
27 September 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 29 Sep 2024
AbbVie submits biologics license application to the FDA for telisotuzumab vedotin in previously treated non-small cell lung cancer
27 September 2024 - Biologics license application submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial ...
Posted by Michael Wonder on 28 Sep 2024
Bayer submits supplemental new drug application to US FDA seeking expanded indication for Nubeqa (darolutamide) in metastatic hormone-sensitive prostate cancer
26 September 2024 - Submission is based on positive results from the investigational pivotal Phase 3 ARANOTE trial that showed Nubeqa ...
Posted by Michael Wonder on 27 Sep 2024
FDA grants fast track designation to PTC518 Huntington's disease program
26 September 2024 - PTC Therapeutics announced today that the FDA has granted fast track designation to the PTC518 program for ...
Posted by Michael Wonder on 27 Sep 2024
FDA approves drug with new mechanism of action for treatment of schizophrenia
26 September 2024 - Today, the US FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment ...
Posted by Michael Wonder on 26 Sep 2024
Pfizer voluntarily withdraws all lots of sickle cell disease treatment Oxbryta (voxelotor) from worldwide markets
25 September 2024 - Pfizer announced today that it is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves new drug to treat Niemann-Pick disease, type C
24 September 2024 - Today, the US FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage ...
Posted by Michael Wonder on 25 Sep 2024
FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025. ...
Posted by Michael Wonder on 24 Sep 2024
Elevar Therapeutics resubmits new drug application to FDA for combination of camrelizumab plus rivoceranib as first-line treatment option for unresectable hepatocellular carcinoma boosted by CARES-310 leading overall survival analysis
23 September 2024 - Elevar Therapeutics today announced the resubmission of a new drug application to the US FDA for its ...