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RSS FeedPosted by Michael Wonder on 18 Dec 2021
bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor
17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...
Posted by Michael Wonder on 18 Dec 2021
FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
17 December 2021 - The FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in paediatric ...
Posted by Michael Wonder on 18 Dec 2021
New treatment for sickle cell disease
17 December 2021 - EMA has recommended granting a marketing authorisation in the EU for Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 18 Dec 2021
Overall survival for oncology drugs approved for genomic indications
17 December 2021 - Drug approvals for genome-informed indications have been increasing in recent years, but it is unknown how many ...
Posted by Michael Wonder on 18 Dec 2021
Astellas and Seagen receive positive CHMP opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
17 December 2021 - If approved, PADCEV would be the first medicine for patients in the EU who have received prior ...
Posted by Michael Wonder on 18 Dec 2021
Tepmetko (tepotinib) receives positive CHMP opinion for patients with advanced NSCLC with METex14 skipping alterations
17 December 2021 - Tepmetko is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe ...
Posted by Michael Wonder on 18 Dec 2021
Tezspire (tezepelumab) approved in the US for severe asthma
17 December 2021 - Only biologic for severe asthma approved with no phenotype or biomarker limitations ...
Posted by Michael Wonder on 17 Dec 2021
FDA approves new treatment for myasthenia gravis
17 December 2021 - The U.S. Food and Drug Administration today approved Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis ...
Posted by Michael Wonder on 16 Dec 2021
EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
16 December 2021 - Rolling review starts in parallel ...
Posted by Michael Wonder on 16 Dec 2021
AVT02, Alvotech’s biosimilar to high concentration formulation of adalimumab (Humira) approved for use in European Union
15 December 2021 - Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira (adalimumab), from the ...
Posted by Michael Wonder on 16 Dec 2021
COVID-19: EMA recommends authorisation of antibody medicine Xevudy
16 December 2021 - EMA’s CHMP has recommended authorising the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19. ...
Posted by Michael Wonder on 16 Dec 2021
Verrica Pharmaceuticals announces acceptance by FDA of NDA resubmission for VP-102 for the treatment of molluscum contagiosum
15 December 2021 - Verrica Pharmaceuticals today announced that the U.S. FDA acknowledged that Verrica’s resubmitted new drug application for VP-102 ...
Posted by Michael Wonder on 16 Dec 2021
EMA recommends approval for use of Kineret in adults with COVID-19
16 December 2021 - EMA’s CHMP has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in ...
Posted by Michael Wonder on 16 Dec 2021
FDA grants Calliditas Therapeutics accelerated approval of Tarpeyo (budesonide) to reduce proteinuria in IgA nephropathy
15 December 2021 - Tarpeyo (developed under the project name Nefecon) is the first and only FDA approved treatment that was ...
Posted by Michael Wonder on 16 Dec 2021
Braeburn receives new complete response letter for Brixadi in the US
15 November 2021 - Camurus today announced that its US licensee Braeburn has received a complete response letter from the US ...