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RSS FeedPosted by Michael Wonder on 03 Jul 2024
"99mTc-maraciclatide" granted FDA fast track designation for the diagnosis of superficial peritoneal endometriosis
2 July 2024 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as a ...
Posted by Michael Wonder on 03 Jul 2024
Novavax submits application to Health Canada for updated protein-based 2024-2025 formula COVID-19 vaccine
2 July 2024 - Novavax's filing is aligned with NACI, US. FDA, EMA and WHO recommendations on vaccine composition. ...
Posted by Michael Wonder on 02 Jul 2024
FDA approves treatment for adults with Alzheimer’s disease
2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...
Posted by Michael Wonder on 02 Jul 2024
FDA breakthrough therapy designation reduced late-stage drug development time
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
Posted by Michael Wonder on 02 Jul 2024
Altos Biologics files for approval of aflibercept biosimilar
1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...
Posted by Michael Wonder on 02 Jul 2024
Standardisation of practice on publication of indications in Swiss Public Assessment Report
1 July 2024 - In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in ...
Posted by Michael Wonder on 02 Jul 2024
Longboard Pharmaceuticals receives breakthrough therapy designation for bexicaserin
1 July 2024 - Longboard Pharmaceuticals today announced that the FDA has granted breakthrough therapy designation for its investigational drug ...
Posted by Michael Wonder on 02 Jul 2024
SpringWorks Therapeutics completes submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
1 July 2024 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application to ...
Posted by Michael Wonder on 02 Jul 2024
Idorsia’s Jeraygo (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension
1 July 2024 - Jeraygo is a new oral antihypertensive therapy – the first in almost 40 years – that is ...
Posted by Michael Wonder on 02 Jul 2024
Pierre Fabre Laboratories announce granting of European marketing authorisation for Obgemsa (vibegron) in overactive bladder
28 June 2024 - The European Commission has authorised the marketing of Obgemsa (vibegron) by Pierre Fabre Laboratories for the symptomatic ...
Posted by Michael Wonder on 02 Jul 2024
Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq
1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...
Posted by Michael Wonder on 02 Jul 2024
Syncromune granted FDA fast track designation for SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer
1 July 2024 - Syncromune today announced that the US FDA has granted fast track designation for SYNC-T SV-102 therapy, its ...
Posted by Michael Wonder on 01 Jul 2024
Neurocrine Biosciences announces US FDA accepts new drug applications and grants priority review for crinecerfont for paediatric and adult patients with CAH
1 July 2024 - PDUFA target action dates in late December 2024. ...
Posted by Michael Wonder on 01 Jul 2024
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 June 2024 - The recommendation is based on the COMMODORE 2 study results, where SC PiaSky given every month demonstrated ...
Posted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...