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RSS FeedPosted by Michael Wonder on 21 Sep 2020
Bristol Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer
18 September 2020 - Application based on results from the Phase 3 CheckMate -9LA trial, which showed significantly improved overall survival ...
Posted by Michael Wonder on 21 Sep 2020
Democratic chairman says White House blocked FDA commissioner from testifying
19 September 2020 - The White House blocked FDA Commissioner Stephen Hahn from testifying before the House panel overseeing the ...
Posted by Michael Wonder on 20 Sep 2020
Sanofi and GSK will provide up to 300 million doses of COVID-19 vaccine to the European Union
18 September 2020 - Agreement signed today supports scale-up of manufacturing capabilities in several European countries. ...
Posted by Michael Wonder on 20 Sep 2020
Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
18 September 2020 - Recommendation is based on the results of the IMbrave150 study, in which the Tecentriq combination improved overall ...
Posted by Michael Wonder on 20 Sep 2020
Almost $6 million poured into three Australian made COVID-19 vaccines
20 September 2020 - The Federal Government will invest almost $6 million to support the development of three Australia made ...
Posted by Michael Wonder on 20 Sep 2020
Ardelyx announces FDA acceptance for filing of its new drug application of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
15 September 2020 - New drug application supported by data from expansive clinical development program demonstrating tenapanor's use as foundational therapy. ...
Posted by Michael Wonder on 20 Sep 2020
In ‘power grab,’ Health Secretary Azar asserts authority over FDA
19 September 2020 - Experts said the memo would make it more difficult for the F.D.A. to issue new rules, but ...
Posted by Michael Wonder on 19 Sep 2020
US FDA grants once daily dosing option for Nityr (nitisinone) tablets for HT-1 patients
14 September 2020 - Cycle Pharmaceuticals is pleased to announce that the U.S. FDA has approved the once daily dosing ...
Posted by Michael Wonder on 19 Sep 2020
Agenus initiates rolling BLA submission of balstilimab for recurrent/metastatic cervical cancer
18 September 2020 - Agenus announced the initiation of the rolling submission of its biologics license application to the U.S. FDA ...
Posted by Michael Wonder on 18 Sep 2020
CHMP recommends approval of Lilly's baricitinib for the treatment of adults with moderate to severe atopic dermatitis
18 September 2020 - Positive opinion is the first regulatory action for baricitinib as an atopic dermatitis medicine. ...
Posted by Michael Wonder on 18 Sep 2020
Highlights from 14-17 September CHMP meeting
18 September 2020 - Seven new medicines recommended for approval. ...
Posted by Michael Wonder on 18 Sep 2020
EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
18 September 2020 - EMA’s CHMP has completed its review of results from the RECOVERY study arm that involved the ...
Posted by Michael Wonder on 17 Sep 2020
Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
16 September 2020 - Next generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly ...
Posted by Michael Wonder on 17 Sep 2020
ChemoCentryx announces FDA acceptance of the avacopan new drug application for the treatment of ANCA associated vasculitis
17 September 2020 - FDA sets PDUFA goal date of 7 July 2021. ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...