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RSS FeedPosted by Michael Wonder on 30 Apr 2026
US FDA grants priority review of new drug application for Gilead’s once daily HIV treatment of bictegravir plus lenacapavir
29 April 2026 - Gilead Sciences today announced the US FDA accepted its new drug application submission for bictegravir 75 mg/lenacapavir ...
Posted by Michael Wonder on 30 Apr 2026
MHRA delivers its targets to increase access to medicines and reinforce UK position as a global destination for life sciences
28 April 2026 - The MHRA continues to speed up access to medicines for patients, increase efficiency of regulation and help ...
Posted by Michael Wonder on 29 Apr 2026
Intellia Therapeutics initiates rolling submission of biologics license application to FDA for lonvoguran ziclumeran as a one time treatment for hereditary angioedema
27 April 2026 - Expect to complete biologics license application submission in second half of 2026; anticipate launch in first ...
Posted by Michael Wonder on 29 Apr 2026
Canada becomes the first G7 country to approve a generic version of semaglutide
28 April 2026 - Today, Health Canada authorised a generic semaglutide injection. This is the first generic semaglutide authorised by Health ...
Posted by Michael Wonder on 29 Apr 2026
FDA announces major steps to implement real time clinical trials
28 April 2026 - The US FDA today announced two major steps as part of an initiative to advance the implementation ...
Posted by Michael Wonder on 28 Apr 2026
AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata
28 April 2026 - Submission is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the ...
Posted by Michael Wonder on 28 Apr 2026
Scancell receives FDA fast track designation for iSCIB1+ in advanced melanoma
28 April 2026 - Scancell Holdings announces that the US FDA has granted fast track designation for its lead ImmunoBody iSCIB1+ ...
Posted by Michael Wonder on 28 Apr 2026
Bepirovirsen accepted for priority review and granted breakthrough therapy designation by the US FDA
28 April 2026 - 26 October 2026 assigned by FDA as PDUFA date. ...
Posted by Michael Wonder on 28 Apr 2026
Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older
28 April 2026 - Approval based on KALOS and LOGOS Phase 3 trials demonstrating statistically significant and clinically meaningful benefits of ...
Posted by Michael Wonder on 28 Apr 2026
Broken PBS system behind failure to list Mounjaro for type 2 diabetics, according to Medicines Australia
28 April 2026 - Hundreds of thousands of Australians with diabetes will continue paying thousands of dollars a year for ...
Posted by Michael Wonder on 28 Apr 2026
FDA approves Caplyta (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
27 April 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental new ddrug application based ...
Posted by Michael Wonder on 28 Apr 2026
FDA grants priority review for Imavvy (nipocalimab-aahu) as the potential first approved treatment for people living with warm auto-immune haemolytic anaemia
27 April 2026 - Johnson & Johnson announced today that the US FDA has granted priority review to the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
Terns Pharmaceuticals announces FDA breakthrough therapy designation granted to TERN-701 for certain patients with chronic myeloid leukaemia
27 April 2026 - Terns Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to TERN-701, a novel, oral ...
Posted by Michael Wonder on 28 Apr 2026
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2 positive locally advanced or metastatic gastric cancer
27 April 2026 - Jazz Pharmaceuticals today announced that the US FDA accepted for filing with priority review the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
Prothena announces Novo Nordisk obtains fast track designation from the US FDA for coramitug (PRX004) in ATTR amyloidosis with cardiomyopathy
27 April 2026 - Prothena today announced that the US FDA has granted fast track designation to coramitug, a potential best ...