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RSS FeedPosted by Michael Wonder on 04 Jun 2020
FDA approves antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
4 June 2020 - Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat ...
Posted by Michael Wonder on 04 Jun 2020
U.S. FDA accepts Pharmaessentia's application for ropeginterferon alfa-2b to treat polycythemia vera
4 June 2020 - U.S. team begins commercial preparations for novel pegylated interferon with appointment of General Manager Meredith Manning. ...
Posted by Michael Wonder on 04 Jun 2020
TVAX Biomedical receives fast track designation from the FDA for brain cancer
4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...
Posted by Michael Wonder on 04 Jun 2020
Patients’ and health care professionals’ organisations updated on EMA’s response to COVID-19
4 June 2020 - EMA updated patients’ and healthcare professionals’ organisations about its COVID-19 activities. ...
Posted by Michael Wonder on 04 Jun 2020
Pierre Fabre receives European approval for Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer
3 June 2020 - European approval is based on the Phase 3 BEACON CRC trial that demonstrated a significant improvement in ...
Posted by Michael Wonder on 04 Jun 2020
New small cell lung cancer drug accepted for TGA evaluation under Project Orbis
3 June 2020 - TGA has granted provisional designation for new drug lurbinectedin based on encouraging Phase 2 results and high ...
Posted by Michael Wonder on 03 Jun 2020
The FDA should not rush a COVID-19 vaccine
2 June 2020 - Vaccines are widely expected to offer the best way out of the COVID-19 pandemic. ...
Posted by Michael Wonder on 03 Jun 2020
Clarity Pharmaceuticals announces that the US FDA grants rare paediatric disease designation to Copper Cu 67 sartate for the treatment of neuroblastoma
3 June 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 03 Jun 2020
Antimicrobial approvals are not bottlenecked by FDA
3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...
Posted by Michael Wonder on 03 Jun 2020
Law makers, government watchdog blast FDA for poor oversight of U.S. drug supply chain
2 June 2020 - A government watchdog blasted the FDA for fumbling its oversight of the safety of the U.S. ...
Posted by Michael Wonder on 03 Jun 2020
Hahn: FDA will make some changes amid COVID-19 permanent
1 June 2020 - The US FDA will look to permanently implement some of the processes and policies adopted in ...
Posted by Michael Wonder on 03 Jun 2020
Zoloft falls into shortage as virus anxiety strains supplies
2 June 2020 - Drug makers blame increase in demand and ingredient shortfall. ...
Posted by Michael Wonder on 03 Jun 2020
The CDC waited its entire existence for this moment. What went wrong?
3 June 2020 - Americans returning from China landed at U.S. airports by the thousands in early February, potential carriers ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 03 Jun 2020
Helsinn Group announces FDA approval of a new liquid formulation of Akynzeo (fosnetupitant/palonosetron) injection in the United States
2 June 2020 - Helsinn today announces that the U.S. FDA has approved the ready-to-dilute liquid formulation of Akynzeo (fosnetupitant/palonosetron) ...