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RSS FeedPosted 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
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 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 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
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 ...
Posted by Michael Wonder on 24 Sep 2021
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted fast track designation by the US FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma
22 September 2021 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a fast track ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
Posted by Michael Wonder on 23 Sep 2021
FDA authorises booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations
22 September 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine to allow ...