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RSS FeedPosted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...
Posted by Michael Wonder on 05 Apr 2022
Watchdog urged to probe McKinsey over work with FDA, opioid manufacturers
5 April 2022 - The consulting firm was getting paid by opioid makers while working for the FDA. ...
Posted by Michael Wonder on 04 Apr 2022
FDA shuts out its own experts in authorising another vaccine booster
3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...
Posted by Michael Wonder on 04 Apr 2022
Precigen receives fast track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukaemia
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
Posted by Michael Wonder on 04 Apr 2022
FDA approves Nobelpharma's Hyftor (sirolimus 0.2% topical gel)
4 April 2022 - Hyftor is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 04 Apr 2022
Acer Therapeutics’ Edsivo (celiprolol) granted FDA breakthrough therapy designation for vascular Ehlers-Danlos syndrome
4 April 2022 - Discussions on-going with FDA through special protocol assessment seeking agreement on planned pivotal Phase 3 DiSCOVER trial ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...
Posted by Michael Wonder on 04 Apr 2022
FDA accepts Dupixent (dupilumab) for priority review in patients aged 12 years and older with eosinophilic oesophagitis
4 April 2022 - If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis. ...
Posted by Michael Wonder on 03 Apr 2022
Cook Medical receives FDA breakthrough device designation for Zenith Thoraco+ endovascular system
31 March 2022 - Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received breakthrough device Designation from the US FDA. ...
Posted by Michael Wonder on 02 Apr 2022
DT-216 granted FDA fast track designation for patients with Friedreich's ataxia
30 March 2022 - DT-216 is a novel GeneTAC gene targeted chimera small molecule designed to specifically target the GAA repeat ...
Posted by Michael Wonder on 02 Apr 2022
Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
31 March 2022 - Robert Califf, the new head of the FDA, admitted Thursday that the agency’s controversial approval of ...
Posted by Michael Wonder on 02 Apr 2022
Y-mAbs announces submission of omburtamab biologics license application to FDA
1 April 2022 - Y-mAbs Therapeutics today announced that on 31 March 2022, the company completed the resubmission of its biologics ...
Posted by Michael Wonder on 01 Apr 2022
FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma
1 April 2022 - Today, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...