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RSS FeedPosted by Michael Wonder on 30 May 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for repotrectinib for the treatment of patients with locally advanced or metastatic ROS1 positive non-small cell lung cancer
30 May 2023 - BMS today announced that the US FDA has accepted the new drug application for repotrectinib, a ...
Posted by Michael Wonder on 24 May 2023
Phathom Pharmaceuticals resubmits erosive GERD new drug application to FDA
23 May 2023 - Anticipated FDA action date in Q4, 2023; if approved, combined launch for erosive gastro-oesophageal reflux disease and H. ...
Posted by Michael Wonder on 24 May 2023
Sarepta Therapeutics announces update on regulatory review of SRP-9001
24 May 2023 - New regulatory action date is 22 June 2023. ...
Posted by Michael Wonder on 22 May 2023
Satsuma Pharmaceuticals announces FDA acceptance of 505(b)(2) NDA for STS101, a novel and investigational dihydroergotamine nasal powder product for the acute treatment of migraine
18 May 2023 - January 2024 PDUFA date expected. ...
Posted by Michael Wonder on 19 May 2023
Bausch + Lomb and Novaliq announce FDA approval of Miebo (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease
18 May 2023 - Miebo is the first and only prescription eye drop approved for dry eye disease that directly targets ...
Posted by Michael Wonder on 18 May 2023
Elevar Therapeutics submits new drug application to FDA for combination of rivoceranib and camrelizumab as first-line treatment option for unresectable hepatocellular carcinoma
17 May 2023 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 17 May 2023
US FDA grants priority review of TAK-755 for the treatment of congenital thrombotic thrombocytopenic purpura
16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation ...
Posted by Michael Wonder on 16 May 2023
U.S. Food and Drug Administration issues complete response letter for Byondis' trastuzumab duocarmazine
15 May 2023 - Complete response letter outlines FDA's request for additional information. ...
Posted by Michael Wonder on 11 May 2023
FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis
9 May 2023 - The objective of this study was to analyse the US FDA approval, trials, unmet needs, benefit, and ...
Posted by Michael Wonder on 11 May 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce FDA approval of Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease
10 May 2023 - PEGylated enzyme replacement therapy designed to provide long half-life. ...
Posted by Michael Wonder on 09 May 2023
FDA accepts application for Genentech’s Vabysmo for the treatment of retinal vein occlusion
9 May 2023 - Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting ...
Posted by Michael Wonder on 09 May 2023
Eyenovia announces FDA approval of Mydcombi, the first ophthalmic spray for mydriasis, which also leverages the company’s proprietary Optejet device platform
8 May 2023 - Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis. ...
Posted by Michael Wonder on 09 May 2023
Vedanta Biosciences receives fast track designation for VE303
8 May 2023 - VE303 receives fast track designation for prevention of recurrent C. difficile infection ahead of global pivotal Phase ...
Posted by Michael Wonder on 09 May 2023
Farxiga extended in the US to reduce risk of cardiovascular death and hospitalisation for heart failure to a broader range of patients
8 May 2023 - FDA approval means patients with heart failure can benefit from Farxiga regardless of left ventricular ejection ...
Posted by Michael Wonder on 06 May 2023
Glaukos announces FDA acceptance of NDA submission for iDose TR
5 May 2023 - PDUFA date set for 22 December 2023. ...