Blog
RSS FeedPosted by Michael Wonder on 08 Jan 2020
FDA – 2019 in review
8 January 2020 - Analysis of NDA approval timelines for 2019. ...
Posted by Michael Wonder on 07 Jan 2020
RadioMedix and Curium announce FDA filing of copper Cu 64 dotatate injection new drug application
7 January 2020 - RadioMedix and its commercial partner Curium announced today that the new drug application for copper Cu 64 ...
Posted by Michael Wonder on 06 Jan 2020
Innovation in new drug approvals of 2019 advances patient care across a broad range of diseases
6 January 2020 - In 2019, the FDA approved a wide variety of new drug therapies to help patients in need. ...
Posted by Michael Wonder on 06 Jan 2020
Challenges to the reproducibility of machine learning models in health care
6 January 2020 - Reproducibility has been an important and intensely debated topic in science and medicine for the past few ...
Posted by Michael Wonder on 06 Jan 2020
Generic makers will appeal ruling that allows California to proceed with law banning pay-to-delay deals
3 January 2020 - A federal judge dealt the pharmaceutical industry a setback by declining to block a new California ...
Posted by Michael Wonder on 06 Jan 2020
FDA approves Fiasp for treatment of children with diabetes
6 January 2020 - Novo Nordisk today announced that the U.S. FDA has approved Fiasp (insulin aspart injection) 100 u/mL for ...
Posted by Michael Wonder on 06 Jan 2020
BridgeBio Pharma’s QED Therapeutics receives fast track designation for infigratinib in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma
6 January 2020 - The PROOF trial, a Phase 3 trial of infigratinib in first-line cholangiocarcinoma, is currently enrolling. ...
Posted by Michael Wonder on 06 Jan 2020
Farxiga granted FDA priority review for patients with heart failure with reduced ejection fraction
6 January 2020 - AstraZeneca today announced the US FDA has accepted a supplemental new drug application and granted Priority ...
Posted by Michael Wonder on 06 Jan 2020
Novel drug approvals for 2019
2 January 2020 - How many of the 'novel' drugs approved by the FDA in 2019 are actually new medicines in ...
Posted by Michael Wonder on 04 Jan 2020
FDA’s deadline problem?
3 January 2020 - Rush to meet end-of-year drug-approval deadlines leads to more adverse effects, new study shows. ...
Posted by Michael Wonder on 31 Dec 2019
Savara granted breakthrough therapy designation for Molgradex for the treatment of auto-immune pulmonary alveolar proteinosis
30 December 2019 - Savara today announced that the U.S. FDA has granted breakthrough therapy designation for Molgradex, an inhaled ...
Posted by Michael Wonder on 31 Dec 2019
Urovant Sciences announces submission of new drug application for vibegron for the treatment of overactive bladder
30 December 2019 - Urovant Sciences announced today that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 31 Dec 2019
MorphoSys announces submission of biologics license application for tafasitamab in r/r DLBCL to the FDA
30 December 2019 - MorphoSys announced today that it has submitted a biologics license application to the U.S. FDA for tafasitamab, ...
Posted by Michael Wonder on 30 Dec 2019
Lynparza approved in the US as a first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer
30 December 2019 - Only PARP inhibitor approved in germline BRCA-mutated metastatic pancreatic cancer. ...
Posted by Michael Wonder on 28 Dec 2019
Luye Pharma submits new drug application in the U.S. for its anti-depressant drug LY03005
26 December 2019 - Luye Pharma Group has announced submission of a new drug application to the U.S. FDA for ...