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 13 May 2021
Daiichi Sankyo submits application for additional indication of mirogabalin in Japan
13 May 2021 - Daiichi Sankyo today announced that it has submitted a supplemental new drug application for mirogabalin besylate ...
Posted by Michael Wonder on 13 May 2021
Fulcrum Therapeutics announces U.S. FDA grants fast track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy
12 May 2021 - Fulcrum Therapeutics today announced that the U.S. FDA has granted fast track designation to losmapimod for ...
Posted by Michael Wonder on 13 May 2021
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 12 years of age and older
13 May 2021 - On 11 May 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer Australia in ...
Posted by Michael Wonder on 12 May 2021
Agenda items scheduled for review by the PBAC under the process for reviewing recommendations not accepted by applicants
13 May 2021 - The revised agenda for the July 2021 PBAC meeting notes seven medicines/medicinal preparations for review under ...
Posted by Michael Wonder on 12 May 2021
TGA approves Octapharma's Cutaquig
12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...
Posted by Michael Wonder on 12 May 2021
BioCryst receives UK approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
12 May 2021 - BioCryst Pharmaceuticals today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted ...
Posted by Michael Wonder on 12 May 2021
Allow Medicare to negotiate on behalf of patients to lower drug prices
12 May 2021 - President Biden’s speech announcing his American Families Plan reaffirmed his strong support for legislation to lower ...
Posted by Michael Wonder on 12 May 2021
Moderna announces new supply agreement with Australia for 25 million doses of its COVID-19 vaccine
12 May 2021 - 25 million doses includes 10 million doses of mRNA-1273 to begin delivery in 2021 and 15 ...
Posted by Michael Wonder on 12 May 2021
Evofem Biosciences receives fast track designation for EVO100 for prevention of gonorrhoea in women
12 May 2021 - Potential for expedited NDA review of EVO100 by FDA. ...
Posted by Michael Wonder on 12 May 2021
Alume Biosciences granted FDA fast track designation of ALM-488 for surgical nerve visualisation
12 May 2021 - Fast track designation highlights the urgent need for improved intra-operative nerve identification. ...
Posted by Michael Wonder on 12 May 2021
Liquidia resubmits new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
10 May 2021 - Liquidia Corporation announced today that on 7 May 2021, it resubmitted its new drug application for LIQ861 ...
Posted by Michael Wonder on 12 May 2021
Astellas’ Xtandi bags additional MHRA approval in prostate cancer
12 May 2021 - Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval ...
Posted by Michael Wonder on 12 May 2021
NICE rejects Pfizer’s rare heart disease treatment Vyndaqel
12 May 2021 - Pfizer’s Vyndaqel has been rejected by NICE as a treatment for the rare heart condition transthyretin ...
Posted by Michael Wonder on 12 May 2021
DermaSensor granted FDA breakthrough device designation
11 May 2021 - FDA designation fast tracks getting cancer detection device in the hands of healthcare professionals ...
Posted by Michael Wonder on 12 May 2021
Public availability of results of ClinicalTrials.gov registered expanded access studies
10 May 2021 - Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies ...