Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2021
Amgen's investigational targeted treatment bemarituzumab granted breakthrough therapy designation
19 April 2021 - Designation is supported by results from the Phase 2 FIGHT trial. ...
Posted by Michael Wonder on 19 Apr 2021
FDA issues final rule removing certain software from medical device regulations
19 April 2021 - The US FDA has issued a final rule making that eliminates certain software intended to transfer, ...
Posted by Michael Wonder on 19 Apr 2021
Fauci says he expects a decision Friday on whether the U.S. can resume using Johnson & Johnson’s vaccine
18 April 2021 - A decision about whether to resume administering the Johnson & Johnson COVID-19 vaccine should come this ...
Posted by Michael Wonder on 19 Apr 2021
United Therapeutics announces submission of Tvyaso DPI new drug application to FDA
19 April 2021 - Priority review voucher applied to the submission. ...
Posted by Michael Wonder on 19 Apr 2021
Agenus submits balstilimab biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
19 April 2021 - Submission has been made for review under the accelerated approval pathway ...
Posted by Michael Wonder on 19 Apr 2021
ALK gains paediatric approval for its ragweed SLIT tablet in the USA
19 April 2021 - The approval is based on data from one of the largest-ever paediatric SLIT-tablet trials, involving over 1,000 ...
Posted by Michael Wonder on 19 Apr 2021
Seagen and Astellas announce U.S. FDA acceptance of two supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
19 April 2021 - Australia and Canada regulators will review applications as part of FDA’s Project Orbis. ...
Posted by Michael Wonder on 16 Apr 2021
FDA revokes emergency use authorisation for monoclonal antibody bamlanivimab
16 April 2021 - Alternative monoclonal antibody therapies authorised to treat patients with COVID-19 remain available. ...
Posted by Michael Wonder on 16 Apr 2021
FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and oesophageal adenocarcinoma
16 April 2021 - Today, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced ...
Posted by Michael Wonder on 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
16 April 2021 - Final step in Lilly's planned transition to provide only bamlanivimab and etesevimab together in the U.S. ...
Posted by Michael Wonder on 16 Apr 2021
Mayne Pharma and Mithra announce FDA approval of new oral contraceptive Estelle
15 April 2021 - Mayne Pharma Group and Mithra Pharmaceuticals are very pleased to announce that the US FDA has approved ...
Posted by Michael Wonder on 15 Apr 2021
White House expands list of potential FDA Commissioners
14 April 2021 - Asian-American and Black doctors on short list of nominees to lead agency. ...
Posted by Michael Wonder on 15 Apr 2021
Perimeter Medical Imaging AI receives U.S. FDA breakthrough device designation for its optical coherence tomography imaging system with ImgAssist AI
15 April 2021 - New designation provides potential pathway to expedite adoption of Perimeter's transformative medical imaging technology combined with artificial ...
Posted by Michael Wonder on 15 Apr 2021
FibroGen receives rare paediatric disease designation from the U.S. FDA for pamrevlumab for the treatment of Duchenne muscular dystrophy
15 April 2021 - FibroGen announced that the U.S. FDA has granted rare paediatric disease designation for the company’s anti-CTGF antibody, ...
Posted by Michael Wonder on 15 Apr 2021
FDA wants more data on promising ALS drug, frustrating patients seeking faster access
15 April 2020 - People living with amyotrophic lateral sclerosis, or ALS, in the U.S. will have to wait longer ...