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RSS FeedPosted by Michael Wonder on 18 Sep 2025
Minovia Therapeutics receives FDA fast track designation for MNV-201 in myelodysplastic syndrome
18 September 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 18 Sep 2025
Alteogen receives European Commission approval for aflibercept biosimilar, Eyluxvi (ALT-L9)
17 September 2025 - Eyluxvi is the second biosimilar approved for Alteogen following the launch of the Herceptin biosimilar in China ...
Posted by Michael Wonder on 18 Sep 2025
Biogen receives European Commission approval for Zurzuvae (zuranolone), the first and only treatment approved for women with postpartum depression in Europe
17 September 2025 - The EC approval of Zurzuvae is based on the SKYLARK study, which demonstrated rapid relief from depressive ...
Posted by Michael Wonder on 18 Sep 2025
Anti-MTBR (microtubule binding region) tau antibody etalanetug granted FDA fast track designation
16 September 2025 - Eisai announced today that etalanetug (E2814), an investigational anti-MTBR (microtubule binding region) tau antibody, was granted fast ...
Posted by Michael Wonder on 17 Sep 2025
Corstasis Therapeutics announces FDA approval of Enbumyst (bumetanide nasal spray) for the treatment of oedema associated with congestive heart failure, liver disease and kidney disease
15 September 2025 - Enbumyst is the first and only intranasal loop diuretic approved in the US offering a self-administered alternative ...
Posted by Michael Wonder on 17 Sep 2025
FDA grants fast track designation to Corbus Pharmaceuticals’ nectin-4 targeting ADC CRB-701 in head and neck squamous cell carcinoma
16 September 2025 - Corbus Pharmaceuticals announced today that the US FDA has granted fast track designation to CRB-701 for the ...
Posted by Michael Wonder on 15 Sep 2025
EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke
15 September 2025 - This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus) reduced ...
Posted by Michael Wonder on 15 Sep 2025
Raludotatug deruxtecan granted breakthrough therapy designation by US FDA for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal or fallopian tube cancers previously treated with bevacizumab
15 September 2025 - Raludotatug deruxtecan has been granted breakthrough therapy designation by the US FDA for the treatment of ...
Posted by Michael Wonder on 12 Sep 2025
Intercept announces voluntary withdrawal of Ocaliva for primary biliary cholangitis from the US market
11 September 2025 - Intercept Pharmaceuticals today announced its decision to voluntarily withdraw Ocaliva (obeticholic acid) from the US market ...
Posted by Michael Wonder on 12 Sep 2025
Johnson & Johnson seeks first EMA approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm
11 September 2025 - Johnson & Johnson today announced the submission of an application to the EMA seeking the first approval ...
Posted by Michael Wonder on 12 Sep 2025
Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
11 September 2025 - Designation earned for a one time intravitreal gene therapy with the potential to eliminate treatment burden for ...
Posted by Michael Wonder on 11 Sep 2025
Enhertu type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumours
11 September 2025 - Submission based on three Phase 2 trials where Daiichi Sankyo and AstraZeneca’s Enhertu showed clinically meaningful ...
Posted by Michael Wonder on 11 Sep 2025
Health Canada approves Slenyto - extended-release melatonin formulation - as a prescription drug for insomnia in children with autism spectrum disorder and Smith-Magenis syndrome
10 September 2025 - Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorisation for Slenyto, an ...
Posted by Michael Wonder on 11 Sep 2025
FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
10 September 2025 - Corcept Therapeutics today announced that the US FDA has accepted Corcept’s new drug application for relacorilant as ...
Posted by Michael Wonder on 10 Sep 2025
Greenwich LifeSciences’ GLSI-100 granted US FDA fast track designation
10 September 2025 - Greenwich LifeSciences today announced that FDA has granted fast track designation for GLSI-100 in the HLA-A*02 patient ...