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RSS FeedPosted by Michael Wonder on 31 Mar 2021
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
31 March 2021 - EMA’s safety committee (PRAC) is meeting today in the context of its ongoing review of very ...
Posted by Michael Wonder on 31 Mar 2021
FDA approves Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma
31 March 2021 - While the median progression free survival for Sarclisa combination therapy is not yet reached, consistent improvement in ...
Posted by Michael Wonder on 31 Mar 2021
Premia Spine announces FDA breakthrough device designation for its TOPS spinal arthroplasty system
31 March 2021 - First-of-a-kind system designed to offer new treatment option for patients with spinal stenosis and spondylolisthesis. ...
Posted by Michael Wonder on 31 Mar 2021
Bluestar Genomics receives FDA breakthrough device designation for first-of-its-kind pancreatic cancer screening test
31 March 2021 - Company accelerates commercialisation efforts to address a million at-risk patients’ unmet needs. ...
Posted by Michael Wonder on 31 Mar 2021
Biden in no rush to pick new FDA chief
30 March 2021 - More than two months into his presidency, President Joe Biden has yet to name someone to lead ...
Posted by Michael Wonder on 31 Mar 2021
Ontozry (cenobamate) receives European Commission approval for the treatment of drug resistant focal onset seizures in adults
30 March 2021 - SK Biopharmaceuticals and Angelini Pharma will collaborate to launch the treatment in countries in the European Economic ...
Posted by Michael Wonder on 31 Mar 2021
Jazz Pharmaceuticals announces FDA approval of additional indication for Vyxeos (daunorubicin and cytarabine) for the treatment of secondary acute myeloid leukaemia in paediatric patients
30 March 2021 - Jazz Pharmaceuticals today announced that the U.S. FDA approved a revised label for Vyxeos (daunorubicin and ...
Posted by Michael Wonder on 31 Mar 2021
Novartis receives EU approval for Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis
30 March 2021 - Approval based on two Phase 3 ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction ...
Posted by Michael Wonder on 31 Mar 2021
Evive Biotech submits biologics license application to US FDA for Ryzneuta
31 March 2021 - Evive is the first Chinese biologics company to advance a novel biologic product from pre-clinical studies to ...
Posted by Michael Wonder on 31 Mar 2021
Roche’s Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy
30 March 2021 - Roche is actively engaging with health authorities in the European Union to achieve broad and rapid access ...
Posted by Michael Wonder on 31 Mar 2021
Amarin receives European Commission approval for Vazkepa to reduce cardiovascular risk
30 March 2021 - Marks first and only European Commission approved treatment to reduce cardiovascular risk in high risk, statin treated ...
Posted by Michael Wonder on 31 Mar 2021
VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the marketing authorisation application for difelikefalin
30 March 2021 - Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics today announced that the EMA accepted to ...
Posted by Michael Wonder on 30 Mar 2021
Terminal cancer patients denied new treatments due to slow TGA approval
31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...
Posted by Michael Wonder on 30 Mar 2021
EMA accepts the marketing authorisation applications for two additional indications of anti-cancer agent lenvatinib in combination with pembrolizumab as a treatment for advanced renal cell carcinoma and advanced endometrial carcinoma
30 March 2021 - Eisai announced today that the EMA has confirmed it has accepted for review applications for the use ...
Posted by Michael Wonder on 30 Mar 2021
Moleculin receives FDA approval of fast track designation for annamycin in the treatment of sarcoma lung metastases
30 March 2021 - Moleculin Biotech today announced that the U.S. FDA has approved its request for fast track designation for ...