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RSS FeedPosted by Michael Wonder on 04 Dec 2021
FDA expands authorisation of two monoclonal antibodies for treatment and post-exposure prevention of COVID-19 to younger paediatric patients, including newborns
3 December 2021 - Today, the U.S. FDA revised the emergency use authorisation of bamlanivimab and etesevimab (previously authorised for paediatric ...
Posted by Michael Wonder on 03 Dec 2021
AbbVie provides update on Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis in the U.S.
3 December 2021 - AbbVie today announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for ...
Posted by Michael Wonder on 03 Dec 2021
FDA approves pembrolizumab for adjuvant treatment of stage IIB or IIC melanoma
3 December 2021 - On 3 December 2021, the FDA approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult ...
Posted by Michael Wonder on 03 Dec 2021
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
3 December 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation have reviewed some of ...
Posted by Michael Wonder on 03 Dec 2021
FDA approves rituximab plus chemotherapy for paediatric cancer indications
3 December 2021 - On 2 December 2021, the FDA approved rituximab (Rituxan, Genentech) in combination with chemotherapy for pediatric ...
Posted by Michael Wonder on 03 Dec 2021
ZetaMet receives breakthrough device designation from U.S. FDA for treatment of metastatic bone cancers
1 December 2021 - The technology is a first of its kind molecular pathway designed to suspend cancer, inhibit pain, and ...
Posted by Michael Wonder on 03 Dec 2021
ATAGI update following weekly COVID-19 meeting (1 December 2021)
3 December 2021 - On 1 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety. ...
Posted by Michael Wonder on 02 Dec 2021
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
2 December 2021 - The EMA’s CHMP has started a rolling review of VLA2001, a COVID-19 vaccine being developed by ...
Posted by Michael Wonder on 02 Dec 2021
CytoDyn submits CMC (manufacturing) section of HIV BLA to FDA under previously authorised rolling review; last (clinical) section will complete full BLA submission
1 December 2021 - FDA may initiate review of this biologics license application under previous rolling review granted to CytoDyn. ...
Posted by Michael Wonder on 02 Dec 2021
COVID-19 vaccine weekly safety report (2 December 2021)
2 December 2021 - To 28 November 2021, the TGA has received 354 reports which have been assessed as likely to ...
Posted by Michael Wonder on 02 Dec 2021
BeyondSpring Pharmaceuticals receives complete response letter from the FDA for plinabulin new drug application for prevention of chemotherapy-induced neutropenia
1 December 2021 - BeyondSpring Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA for the ...
Posted by Michael Wonder on 02 Dec 2021
Pfizer Canada initiates submission to Health Canada for COVID-19 oral anti-viral candidate
1 December 2021 - Pfizer Canada today initiated the filing of a rolling new drug submission with Health Canada for its ...
Posted by Michael Wonder on 02 Dec 2021
TGA provisional approval of Roche COVID-19 treatment, tocilizumab (Actemra)
1 December 2021 - On 1 December 2021, the TGA granted provisional approval to Roche for the use of tocilizumab ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA grants Bionomics fast track designation to BNC210 for the acute treatment of social anxiety disorder and other anxiety related disorders
1 December 2021 - Bionomics is pleased to announce that the U.S. FDA has granted fast track designation to the ...
Posted by Michael Wonder on 01 Dec 2021
BioXcel Therapeutics announces extension of FDA review period of its NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders
1 December 2021 - PDUFA date extended by three months to 5 April 2022. ...