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RSS FeedPosted by Michael Wonder on 29 Sep 2021
EMA implements new measures to minimise animal testing during medicines development
29 September 2021 - EMA is putting in place special support to developers to replace, reduce and refine animal use for ...
Posted by Michael Wonder on 29 Sep 2021
Nonagen Bioscience granted FDA breakthrough device designation
28 September 2021 - Nonagen Bioscience today announced Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has ...
Posted by Michael Wonder on 29 Sep 2021
Selux Diagnostics earns FDA breakthrough device designation for next generation phenotyping platform for positive blood culture and sterile body fluid samples
28 September 2021 - Selux next generation phenotyping now qualifies for expedited FDA review process as single-platform technology for rapid antimicrobial ...
Posted by Michael Wonder on 29 Sep 2021
Novian Health gains FDA breakthrough designation for Novilase breast therapy
28 September 2021 - Novian Health has been granted breakthrough device designation from the U.S. FDA for its Novilase Interstitial Laser ...
Posted by Michael Wonder on 29 Sep 2021
FDA approves Qulipta (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine
27 September 2021 - Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days among adults ...
Posted by Michael Wonder on 29 Sep 2021
FDA expands Lilly's Erbitux (cetuximab) label with combination of Braftovi (encorafenib) for the treatment of BRAF V600E mutation positive metastatic colorectal cancer after prior therapy
28 September 2021 - Erbitux is the first and only anti-EGFR antibody approved, in combination with encorafenib, specifically for adults ...
Posted by Michael Wonder on 28 Sep 2021
Pfizer and BionNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
28 September 2021 - Formal submission to request Emergency Use Authorization to follow in the coming weeks. ...
Posted by Michael Wonder on 28 Sep 2021
TGA grants provisional determination to Roche COVID-19 treatment tocilizumab (Actemra)
28 September 2021 - On 27 September 2021, the TGA granted provisional determination to Roche in relation to the COVID-19 ...
Posted by Michael Wonder on 28 Sep 2021
Lipocine announces FDA affirmation of Class 1 NDA resubmission for Tlando
28 September 2021 - Lipocine today announced the U.S. FDA has affirmed the resubmission of its new drug application for Tlando, ...
Posted by Michael Wonder on 28 Sep 2021
FDA grants priority review to ViiV Healthcare’s new drug application for cabotegravir long-acting for prevention of HIV
28 September 2021 - Final FDA decision anticipated by 24 January 2022; if approved, cabotegravir would be the first long-acting ...
Posted by Michael Wonder on 28 Sep 2021
FDA accepts Libtayo (cemiplimab-rwlc) for priority review for advanced cervical cancer
28 September 2021 - European Union regulatory submission planned by end of 2021. ...
Posted by Michael Wonder on 28 Sep 2021
Eisai initiates rolling submission to the U.S. FDA for biologics license application of lecanemab (BAN2401) for early Alzheimer's disease under the accelerated approval pathway
28 September 2021 - Eisai and Biogen today announced that Eisai has initiated a rolling submission to the U.S. FDA of ...
Posted by Michael Wonder on 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 2021. ...
Posted by Michael Wonder on 27 Sep 2021
Gilead marks fifth approval for Trodelvy in metastatic triple negative breast cancer under Project Orbis initiative with Health Canada authorisation
27 September 2021 - Antibody-drug conjugate Trodelvy is first treatment to show survival benefit versus standard of care in metastatic triple ...
Posted by Michael Wonder on 27 Sep 2021
Canadian cancer patients have new affordable treatment option
27 September 2021 - Apobiologix expanded its leadership in Canada's biosimilar market with the approval of its first therapeutic treatment, Bambevi. ...