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RSS FeedPosted by Michael Wonder on 01 Jul 2020
Sun BioPharma receives FDA fast track designation for SBP-101
30 June 2020 - Sun BioPharma today announced receipt of fast track designation from the U.S. FDA for its lead product, ...
Posted by Michael Wonder on 01 Jul 2020
Oncopeptides submits a new drug application to the FDA for accelerated approval of Melflufen in triple-class refractory multiple myeloma patients
30 June 2020 - Oncopeptides today announces that the Company submits a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 30 Jun 2020
MediWound announces submission of biologics license application to the US FDA for NexoBrid for the treatment of severe thermal burns
30 June 2020 - MediWound today announced it has submitted a biologics license application to the US FDA seeking the ...
Posted by Michael Wonder on 30 Jun 2020
Ultragenyx announces U.S. FDA approval of Dojolvi (UX007/triheptanoin), the first FDA approved therapy for the treatment of long-chain fatty acid oxidation disorders
30 June 2020 - Fourth U.S. FDA approval for Ultragenyx in the past three years – all for rare diseases which ...
Posted by Michael Wonder on 30 Jun 2020
FDA takes action to help facilitate timely development of safe, effective COVID-19 vaccines
30 June 2020 - Today, the U.S. FDA took important action to help facilitate the timely development of safe and effective ...
Posted by Michael Wonder on 30 Jun 2020
EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...
Posted by Michael Wonder on 30 Jun 2020
Nordic Nanovector's Betalutin receives fast track designation from US FDA for marginal zone lymphoma
29 June 2020 - Nordic Nanovector today announces that the US FDA has granted fast track designation for investigating Betalutin (177Lu ...
Posted by Michael Wonder on 30 Jun 2020
Heron Therapeutics receives complete response letter for HTX-011 for the management of post-operative pain
29 June 2020 - Complete response letter requests additional non-clinical information. ...
Posted by Michael Wonder on 29 Jun 2020
Cancer Prevention Pharmaceuticals submits new drug application to the FDA for CPP-1X/sul for treatment of familial adenomatous polyposis
29 June 2020 - Company seeks accelerated approval for cancer drug. ...
Posted by Michael Wonder on 29 Jun 2020
Gilead sets price for coronavirus drug remdesivir at $2,340, sparking criticism
30 June 2020 - The maker of a drug shown to shorten recovery time for severely ill COVID-19 patients says ...
Posted by Michael Wonder on 29 Jun 2020
FDA approves first-line immunotherapy for patients with MSI-H/dMMR metastatic colorectal cancer
26 June 2020 - Today, the U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment ...
Posted by Michael Wonder on 29 Jun 2020
FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer
29 June 2020 - Today the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf ...
Posted by Michael Wonder on 29 Jun 2020
Intercept receives complete response letter from FDA for obeticholic acid for the treatment of fibrosis due to NASH
29 June 2020 - Intercept Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 29 Jun 2020
New medicine for cystic fibrosis patients
26 June 2020 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, ...
Posted by Michael Wonder on 29 Jun 2020
Samsung Bioepis receives positive CHMP opinion for Aybintio (bevacizumab)
26 June 2020 - Abbintio, a biosimilar candidate referencing Avastin (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for ...