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RSS FeedPosted by Michael Wonder on 19 Sep 2025
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
19 September 2025 - Today, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult ...
Posted by Michael Wonder on 19 Sep 2025
Biocon Biologics receives US FDA approval for Bosaya and Aukelso, denosumab biosimilars
17 September 2025 - Biocon Biologics today announced that the US FDA has approved Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous ...
Posted 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
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
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
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
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 ...
Posted by Michael Wonder on 10 Sep 2025
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
10 September 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) granules and capsules for paediatric patients 1 year ...
Posted by Michael Wonder on 10 Sep 2025
FDA accepts biologics license application for Sobi's NASP for patients with uncontrolled gout
10 September 2025 - Sobi today announced that the US FDA has accepted the biologics license application seeking approval for Nanoecapsulated ...
Posted by Michael Wonder on 10 Sep 2025
US FDA approval of Inlexzo (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
9 September 2025 - First and only drug releasing system to provide extended local delivery of a cancer medication into the ...
Posted by Michael Wonder on 10 Sep 2025
Teva’s emrusolmin granted US FDA fast track designation for treatment of multiple system atrophy
9 September 2025 - Teva Pharmaceuticals today announced that the US FDA granted fast track designation for Teva’s investigational therapy emrusolmin ...