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RSS FeedPosted by Michael Wonder on 20 Jun 2020
Nabriva Therapeutics receives complete response letter from FDA on NDA for Contepo (fosfomycin) for injection
19 June 2020 - Agency cited travel restrictions and inability to conduct onsite inspections to resolve observations at manufacturing partner facilities. ...
Posted by Michael Wonder on 20 Jun 2020
FDA approves Evoke’s Gimoti
19 June 2020 - Commercial partner Eversana prepares for Gimoti launch. ...
Posted by Michael Wonder on 20 Jun 2020
Plakous Therapeutics receives rare paediatric disease and orphan drug designations for Protego-PDTM for the prevention of necrotising enterocolitis
18 June 2020 - Plakous Therapeutics has been granted orphan drug and rare paediatric disease designations for its human placental extract, ...
Posted by Michael Wonder on 20 Jun 2020
Ovid Therapeutics receives FDA rare paediatric disease designation for OV101 for the treatment of Angelman syndrome
19 June 2020 - Ovid Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease ...
Posted by Michael Wonder on 19 Jun 2020
Dicerna receives rare paediatric disease designation from U.S. FDA for nedosiran for the treatment of primary hyperoxaluria
18 June 2020 - Dicerna Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation for nedosiran, ...
Posted by Michael Wonder on 18 Jun 2020
FDA takes additional action to harness real world data to inform COVID-19 response efforts
18 June 2020 - Today the U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to ...
Posted by Michael Wonder on 18 Jun 2020
Clinical trial costs to develop a new drug may actually be rather modest — or so one study suggests
18 June 2020 - For years, the pharmaceutical industry has maintained that the costs to develop medicines accounts for rising ...
Posted by Michael Wonder on 18 Jun 2020
Linnaeus Therapeutics granted U.S. FDA fast track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on anti-PD-1/L1 therapy
18 June 2020 - Company Conducting Ongoing Phase 1/2 Study of LNS8801. ...
Posted by Michael Wonder on 18 Jun 2020
FDA granted accelerated approval to tazemetostat for follicular lymphoma
18 June 2020 - Today the Food and Drug Administration granted accelerated approval to tazemetostat (Tazverik, Epizyme), an EZH2 inhibitor, ...
Posted by Michael Wonder on 18 Jun 2020
FDA approves first therapy for rare disease that causes low phosphate blood levels, bone softening
18 June 2020 - Today, the U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and ...
Posted by Michael Wonder on 18 Jun 2020
TG Therapeutics completes rolling submission of new drug application to the U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma
17 June 2020 - TG Therapeutics today announced the completion of the rolling submission of a new drug application to the ...
Posted by Michael Wonder on 18 Jun 2020
Chi-Med announces fruquintinib granted U.S. FDA fast track designation for metastatic colorectal cancer
18 June 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 17 Jun 2020
Identifying the risks of unproven regenerative medicine therapies
17 June 2020 - In the middle of the coronavirus disease 2019 public health response, many priorities are currently competing for ...
Posted by Michael Wonder on 17 Jun 2020
Ipsen receives FDA fast track designation for liposomal irinotecan (Onivyde) as a first-line combination treatment for metastatic pancreatic cancer
17 June 2020 - Final analysis of the Phase 1/2 clinical study to be presented as a late-breaking virtual presentation at ...
Posted by Michael Wonder on 17 Jun 2020
FDA approves pembrolizumab for adults and children with TMB-H solid tumours
17 June 2020 - On 16 June 2020, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment ...