Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2024
Nora Pharma receives Health Canada approval for Niopeg, a biosimilar of Neulasta
19 April 2024 - Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the ...
Posted by Michael Wonder on 20 Apr 2024
Health Canada approves Keytruda as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
19 April 2024 - Approval is based on the Phase 3 KEYNOTE-859 trial. ...
Posted by Michael Wonder on 19 Apr 2024
US FDA approves subcutaneous administration of Takeda’s Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
19 April 2024 - Entyvio is now available in the US in both intravenous and subcutaneous administrations for maintenance treatment ...
Posted by Michael Wonder on 18 Apr 2024
Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
Posted by Michael Wonder on 18 Apr 2024
AskBio receives FDA fast track designation for AB-1002 investigational gene therapy program in congestive heart failure
18 April 2024 - AB-1002 is being studied for the treatment of adults with non-ischaemic cardiomyopathy and New York Heart Association ...
Posted by Michael Wonder on 18 Apr 2024
FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK positive early stage lung cancer
18 April 2024 - Approval based on Phase 3 ALINA study showing Alecensa reduced the risk of disease recurrence or death ...
Posted by Michael Wonder on 18 Apr 2024
COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
Posted by Michael Wonder on 16 Apr 2024
Lexeo Therapeutics granted FDA fast track designation for LX2006, an AAV based gene therapy candidate for the treatment of Friedreich’s ataxia cardiomyopathy
16 April 2024 - Lexeo Therapeutics today announced the US FDA has granted fast track designation to LX2006, the company’s AAVrh.10hFXN ...
Posted by Michael Wonder on 16 Apr 2024
GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...
Posted by Michael Wonder on 16 Apr 2024
TLX101-CDx (Pixclara) granted FDA fast track designation
16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...
Posted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
Posted by Michael Wonder on 12 Apr 2024
Formycon announces commercial launch of FYB201 (ranibizumab) in Canada (Ranopto) and Switzerland (Ranivisio)
11 April 2024 - Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto and in Switzerland under the trademark ...
Posted by Michael Wonder on 11 Apr 2024
PureTech receives FDA fast track designation for LYT-200 in head and neck cancers
11 April 2024 - LYT-200 is being evaluated in locally advanced/metastatic solid tumours, including head and neck cancers, as well as ...
Posted by Michael Wonder on 11 Apr 2024
Fasenra approved for treatment of children aged 6 to 11 with severe asthma
11 April 2024 - AstraZeneca’s Fasenra (benralizumab) is now approved by the US FDA for add-on maintenance treatment for patients ...