Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2020
Hikma updates on ANDA for generic Advair Diskus
22 September 2020 - Hikma Pharmaceuticals announces that it has received a minor complete response letter from the US FDA ...
Posted by Michael Wonder on 22 Sep 2020
Medeor Therapeutics’ transplant immune tolerance therapy receives regenerative medicine advanced therapy designation from FDA
22 September 2020 - Medeor Therapeutics today announced that the U.S. FDA has granted a regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 22 Sep 2020
U.S. FDA accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)
22 September 2020 - Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma. ...
Posted by Michael Wonder on 22 Sep 2020
FDA launches the Digital Health Center of Excellence
22 September 2020 - Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence ...
Posted by Michael Wonder on 22 Sep 2020
Gyroscope Therapeutics granted FDA fast track designation for GT005, an investigational gene therapy for dry age-related macular degeneration
22 September 2020 - Gyroscope Therapeutics today announced that the U.S. FDA has granted fast track designation to GT005 for the ...
Posted by Michael Wonder on 22 Sep 2020
ADC Therapeutics submits biologics license application to the U.S. FDA for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
21 September 2020 - Submission based on efficacy and safety data from LOTIS 2 clinical trial. ...
Posted by Michael Wonder on 21 Sep 2020
You can trust the FDA’s vaccine process
20 September 2020 - The agency can roll out a Covid shot safely, quickly and without bowing to political pressure. ...
Posted by Michael Wonder on 21 Sep 2020
Crinetics Pharmaceuticals receives rare paediatric disease designation from FDA for CRN04777 for the treatment of congenital hyperinsulinism
21 September 2020 - Crinetics Pharmaceuticals today announced that the U.S. Food and Drug FDA has granted rare paediatric disease designation ...
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
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 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. ...