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RSS FeedPosted 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. ...
Posted by Michael Wonder on 27 Sep 2021
U.S. Food and Drug Administration accepts Bristol Myers Squibb’s applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + chemotherapy for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
27 September 2021 - Applications based on Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated a significant overall survival ...
Posted by Michael Wonder on 27 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...
Posted by Michael Wonder on 26 Sep 2021
Australia secures supply of drug that treats arthritis and Covid
25 September 2021 - Health Minister Greg Hunt has secured an extra supply of a rheumatoid arthritis drug to treat critically ...
Posted by Michael Wonder on 26 Sep 2021
FDA tweaks biosimilar application review program
25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. ...
Posted by Michael Wonder on 25 Sep 2021
CARISMA Therapeutics announces U.S. FDA grants fast track designation to CT-0508 for the treatment of patients with solid tumours
22 September 2021 - CARISMA Therapeutics announced today that that the U.S. FDA has granted fast track designation to CT-0508, ...
Posted by Michael Wonder on 25 Sep 2021
FDA approves Repatha (evolocumab) in paediatric patients age 10 and older with heterozygous familial hypercholesterolaemia
24 August 2021 - Approval based on HAUSER RCT demonstrating a significant reduction in low-density lipoprotein cholesterol. ...
Posted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...
Posted by Michael Wonder on 25 Sep 2021
Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...