Blog
RSS FeedPosted by Michael Wonder on 21 Apr 2022
Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines
21 April 2022 - PDUFA goal date set for 8 September 2022. ...
Posted by Michael Wonder on 21 Apr 2022
Zambon receives U.S. FDA breakthrough therapy designation for CMS I-neb in patients with non-cystic fibrosis bronchiectasis
21 April 2022 - CMS I-neb is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients ...
Posted by Michael Wonder on 20 Apr 2022
Extrapolation of drug indications from study populations by FDA is ‘common’
19 April 2022 - Extrapolation of indications in new drug approvals by the U.S. FDA to populations not originally studied ...
Posted by Michael Wonder on 20 Apr 2022
New drug application resubmission update
20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm ...
Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
Posted by Michael Wonder on 20 Apr 2022
Teva and MedinCell receive complete response letter for TV-46000/mdc-IRM
19 April 2022 - Teva Pharmaceuticals and MedinCell announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 20 Apr 2022
FDA granted CMG901 fast track designation for unresectable or metastatic gastric and gastro-oesophageal junction cancer which have relapsed and/or are refractory to approved therapies
19 April 2022 - Keymed Biosciences announced that the U.S. FDA granted CMG901 fast track designation as monotherapy for the ...
Posted by Michael Wonder on 19 Apr 2022
Medicare’s decision not to fund Aduhelm changes landscape for US pharma industry
19 April 2022 - The decision by the agency responsible for Medicare to restrict coverage of Biogen’s Alzheimer’s drug aducanumab ...
Posted by Michael Wonder on 19 Apr 2022
Innovative Cellular Therapeutics receives FDA fast track designation for GCC19CART, its lead solid tumour candidate, in the treatment of patients with relapsed or refractory metastatic colorectal cancer
19 April 2022 - GCC19CART is an autologous CAR T therapy candidate that has shown promising results in over 30 relapsed ...
Posted by Michael Wonder on 19 Apr 2022
Aytu BioPharma announces fast track designation granted to AR101 for the treatment of vascular Ehlers-Danlos syndrome
19 April 2022 - Aytu BioPharma today announced that the U.S. FDA has granted fast track designation to AR101 (enzastaurin), a ...
Posted by Michael Wonder on 19 Apr 2022
Adicet Bio receives FDA fast track designation for lead candidate ADI-001
19 April 2022 - Adicet Bio today announced the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 19 Apr 2022
US Food and Drug Administration accepts new drug application for daprodustat
19 April 2022 - Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase 3 ...
Posted by Michael Wonder on 19 Apr 2022
Enhertu granted priority review in the U.S. for patients with previously treated HER2 mutant metastatic non-small-cell lung cancer
19 April 2022 - Based on pivotal DESTINY-Lung01 results showing Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a 54.9% tumour response ...
Posted by Michael Wonder on 18 Apr 2022
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
18 April 2022 - Five years ago, the FDA launched a new program with the best of intentions: to speed ...
Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...