Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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
PHARMAC in review (2021)
2 December 2021 - Another dismal year in terms of the number of new medicines listed in the New Zealand ...
Posted by Michael Wonder on 01 Dec 2021
Lilly Canada concludes successful negotiation with the Pan-Canadian Pharmaceutical Alliance for Baqsimi (glucagon nasal powder)
30 November 2021 - Lilly Canada is pleased to announce the completion of a successful negotiation with the pan-Canadian Pharmaceutical Alliance ...
Posted by Michael Wonder on 01 Dec 2021
ICER publishes first annual assessment of barriers to fair access within US commercial insurance prescription drug coverage
1 December 2021 - Scope of assessment limited by gaps in availability of payer policies and inability to evaluate how policies ...
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. ...
Posted by Michael Wonder on 01 Dec 2021
FDA approves Darzalex Faspro, Kyprolis, and dexamethasone for multiple myeloma
1 December 2021 - On 30 November 2021, the FDA approved daratumumab with hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with ...
Posted by Michael Wonder on 01 Dec 2021
Zogenix announces U.S. FDA acceptance for priority review of supplemental new drug application for Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
1 December 2021 - Prescription Drug User Fee Act target action date of 25 March 2022. ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA accepts for priority review the supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 December 2021 - Merck today announced the U.S. FDA has accepted for priority review a supplemental biologics license application for ...
Posted by Michael Wonder on 01 Dec 2021
VBI Vaccines announces FDA approval of PreHevbrio for the prevention of Hepatitis B in adults
1 December 2021 - PreHevbrio is the only approved 3 antigen hepatitis B vaccine for adults in the U.S. ...
Posted by Michael Wonder on 01 Dec 2021
Huyabio International receives regulatory approval for Hiyasta monotherapy of peripheral T-cell lymphoma In Japan
30 November 2021 - This is the second indication for Hiyasta in Japan following adult T-cell leukaemia/lymphoma. ...
Posted by Michael Wonder on 01 Dec 2021
Fennec Pharmaceuticals receives complete response letter from the US FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic, solid tumours
30 November 2021 - Fennec Pharmaceuticals today announced that it received a complete response letter on 29 November 2021 from the ...
Posted by Michael Wonder on 01 Dec 2021
Secura Bio announces U.S. withdrawal of Farydak (panobinostat)
30 November 2021 - Secura Bio announced today that, based on discussions with the U.S. FDA, Secura Bio has submitted to ...