Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2020
Genmab announces that Janssen has submitted a biologics license application to U.S. FDA for amivantamab in non-small cell lung cancer
3 December 2020 - First regulatory submission for a DuoBody product candidate. ...
Posted by Michael Wonder on 02 Dec 2020
BridgeBio Pharma and Affiliate QED Therapeutics announce FDA acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma
1 December 2020 - Application will also be submitted for review in Australia and Canada under Project Orbis. ...
Posted by Michael Wonder on 02 Dec 2020
Amicus Therapeutics initiates rolling biologic license application to the U.S. FDA for AT-GAA in late-onset Pompe disease
1 December 2020 - On track for completing the BLA submission in 1H2021. ...
Posted by Michael Wonder on 02 Dec 2020
TG Therapeutics initiates rolling submission of biologics license application to U.S. FDA for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic leukaemia
1 December 2020 - Completion of rolling submission for the BLA expected in 1H21. ...
Posted by Michael Wonder on 01 Dec 2020
VBI Vaccines announces submission of biologics license application to FDA for 3 antigen prophylactic hepatitis B vaccine
1 December 2020 - VBI Vaccines today announced the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 01 Dec 2020
Kadmon announces FDA acceptance of NDA for belumosudil in patients with chronic graft versus host disease
30 November 2020 - Application being evaluated Under FDA's Real-Time Oncology Review and Project Orbis pilot programs. ...
Posted by Michael Wonder on 30 Nov 2020
Moderna submits vaccine for FDA regulatory approval
30 November 2020 - Recent vaccine developments have been met with optimism among scientists and stock markets, but experts also urge ...
Posted by Michael Wonder on 26 Nov 2020
FDA defers approval of daxibotulinumtoxinA for injection in glabellar lines due to COVID-19 related travel restrictions impacting manufacturing site inspection
25 November 2020 - Revance Therapeutics today announced that the United States FDA has deferred a decision on the biologics license ...
Posted by Michael Wonder on 24 Nov 2020
Telix new drug application for prostate cancer imaging product accepted by US FDA
24 November 2020 - Telix Pharmaceuticals announces new drug application for TLX591-CDx. ...
Posted by Michael Wonder on 24 Nov 2020
Merck submits applications for licensure of V114, the company’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults to the US FDA and EMA
23 November 2020 - Merck today announced the company has submitted applications to the US FDA and EMA for licensure of ...
Posted by Michael Wonder on 23 Nov 2020
Kiniksa announces U.S. FDA acceptance of sBLA and priority review for rilonacept in recurrent pericarditis
23 November 2020 - Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints. ...
Posted by Michael Wonder on 21 Nov 2020
ADC Therapeutics announces FDA accepts biologics license application and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
20 November 2020 - Prescription Drug User Fee Act target action date of 21 May 2021. ...
Posted by Michael Wonder on 21 Nov 2020
Pfizer and BioNTech to submit emergency use authorisation request today to the U.S. FDA for COVID-19 vaccine
20 November 2020 - In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted by Michael Wonder on 19 Nov 2020
Omeros submits its biologics license application to U.S. FDA for narsoplimab in HSCT-TMA
18 November 2020 - Omeros Corporation announced that it has completed the rolling submission of its biologics license application to ...