Blog
RSS FeedPosted by Michael Wonder on 03 May 2021
TGA approves key label updates to Buvidal for treatment of opioid dependence
3 May 2021 - Camurus today announced that the Australian regulatory agency, the TGA, has approved key label updates to ...
Posted by Michael Wonder on 03 May 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 03 May 2021
Hutchmed completes rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
3 May 2021 - First NDA submission by Hutchmed in the U.S.; product launch preparations underway. ...
Posted by Michael Wonder on 03 May 2021
Statement from Health Canada on Janssen COVID-19 vaccines and Emergent BioSolutions
30 April 2021 - Health Canada continues to ensure the quality and safety of vaccines coming into Canada by working ...
Posted by Michael Wonder on 03 May 2021
ALS groups to the FDA and drug sponsors: ‘We won’t be played again’
30 April 2021 - Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as Lou ...
Posted by Michael Wonder on 03 May 2021
Chiesi Global Rare Diseases announces FDA approval of Ferriprox (deferiprone) for treatment of transfusional iron overload due to sickle cell disease
1 May 2021 - Approval is based on demonstrated reduction in liver iron concentration. ...
Posted by Michael Wonder on 03 May 2021
FDA scraps another last-minute Trump-era policy
30 April 2021 - The US FDA on Friday revoked a policy issued in the final days of the Trump ...
Posted by Michael Wonder on 03 May 2021
BioCryst receives European Commission approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
30 April 2021 - BioCryst Pharmaceuticals today announced that the European Commission has approved oral, once daily Orladeyo (berotralstat) for ...
Posted by Michael Wonder on 01 May 2021
Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European ...
Posted by Michael Wonder on 30 Apr 2021
FDA approves higher dosage of naloxone nasal spray to treat opioid overdose
30 April 2021 - The U.S. FDA announced today the approval of a higher dose naloxone hydrochloride nasal spray product to ...
Posted by Michael Wonder on 30 Apr 2021
FDA approves treatment for chronic kidney disease
30 April 2021 - Approval is first to cover many causes of disease. ...
Posted by Michael Wonder on 30 Apr 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo. ...
Posted by Michael Wonder on 30 Apr 2021
Update on U.S. FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis
29 April 2021 - FDA has requested additional data relating to a device component of tralokinumab. ...
Posted by Michael Wonder on 30 Apr 2021
Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication
29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...