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RSS FeedPosted by Michael Wonder on 09 Dec 2020
Even before year end, 2020's new drug approvals match FDA's 2019 stats
7 December 2020 - The US FDA has kept its new drug approvals for 2020 on track to match or ...
Posted by Michael Wonder on 08 Dec 2020
Trump Administration passed on chance to secure more of Pfizer vaccine
7 December 2020 - The pharmaceutical company offered the government a chance to lock in additional supplies before its vaccine was ...
Posted by Michael Wonder on 08 Dec 2020
Telix granted TGA priority review for prostate cancer imaging
7 December 2020 - Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...
Posted by Michael Wonder on 08 Dec 2020
Carlsmed aprevo granted unprecedented decision by FDA
8 December 2020 - -Carlsmed today announced it has been granted 510(k) clearance and breakthrough device designation by the FDA for ...
Posted by Michael Wonder on 08 Dec 2020
Turning Point Therapeutics granted FDA breakthrough therapy designation for repotrectinib treatment in patients with ROS1 positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor
8 December 2020 - Updated data from TRIDENT-1 study in tyrosine kinase inhibitor naïve patients with ROS1 positive non-small cell lung ...
Posted by Michael Wonder on 08 Dec 2020
Pfizer's vaccine offers COVID-19 protection after first dose, FDA says
9 December 2020 - Pfizer has cleared the next hurdle in the race to get its COVID-19 vaccine approved for ...
Posted by Michael Wonder on 08 Dec 2020
Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
8 December 2020 - The EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for ...
Posted by Michael Wonder on 08 Dec 2020
CDER focuses on novel drug development tools to help speed creation of new therapies
7 December 2020 - There are many novel drug development tools that incorporate the latest advances in science and technology but ...
Posted by Michael Wonder on 07 Dec 2020
EMA publishes agenda for 7-10 December CHMP meeting
7 December 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 07 Dec 2020
FDA could authorise Pfizer’s COVID-19 vaccine this week as U.S. deaths surge
7 December 2020 - An FDA advisory group is scheduled to convene on Thursday to review Pfizer’s vaccine. ...
Posted by Michael Wonder on 07 Dec 2020
Immunicum receives FDA fast track designation for ilixadencel in gastro-intestinal stromal tumours
7 December 2020 - Immunicum announced today that it has received fast track designation from the U.S. FDA for the Company’s ...
Posted by Michael Wonder on 07 Dec 2020
Scynexis announces FDA acceptance and priority review of new drug application for oral ibrexafungerp for the treatment of vaginal yeast infections
7 December 2020 - 6 month Priority Review granted for ibrexafungerp with PDUFA target action date set for 1 June 2021. ...
Posted by Michael Wonder on 07 Dec 2020
Chimerix announces FDA acceptance of new drug application for brincidofovir as a medical countermeasure for smallpox
7 December 2020 - Chimerix today announced that the U.S. FDA has accepted the filing of a new drug application ...
Posted by Michael Wonder on 07 Dec 2020
scPharmaceuticals receives complete response letter from FDA for Furoscix
7 December 2020 - Complete response letter did not identify clinical deficiencies. ...
Posted by Michael Wonder on 07 Dec 2020
Janssen seeks EU approval for twice yearly schizophrenia treatment
7 December 2020 - Janssen has submitted a marketing authorisation extension application to the EMA for paliperidone palmitate six monthly ...