Blog
RSS FeedPosted by Michael Wonder on 15 Sep 2021
U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma
15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...
Posted by Michael Wonder on 15 Sep 2021
Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs
14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...
Posted by Michael Wonder on 15 Sep 2021
ObsEva announces submission of new drug application to U.S. FDA for linzagolix for the treatment of uterine fibroids
15 September 2021 - NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and ...
Posted by Michael Wonder on 15 Sep 2021
PDUFA goal date extension for Nefecon NDA in the U.S.
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its ...
Posted by Michael Wonder on 14 Sep 2021
ISA Pharmaceuticals receives fast track designation for lead product ISA101b
14 September 2021 - Fast track designation for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer to improve ...
Posted by Michael Wonder on 14 Sep 2021
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-07 for the acute treatment of migraine
14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 14 Sep 2021
Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio system for obstructive sleep apnea and complete concentric collapse
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough ...
Posted by Michael Wonder on 14 Sep 2021
A court decision on “skinny labeling” another challenge for less expensive drugs
13 September 2021 - Brand name drugs, such as apixaban (Eliquis) and lenalidomide (Revlimid), account for approximately 80% of US drug ...
Posted by Michael Wonder on 13 Sep 2021
Reimagining pharmaceutical market exclusivities: should the duration of guaranteed monopoly periods be value based?
13 September 2021 - The amount of time in which brand pharmaceutical markets are protected does not correspond with the products’ ...
Posted by Michael Wonder on 13 Sep 2021
BeiGene announces U.S. FDA acceptance of biologics license application for tislelizumab in oesophageal squamous cell carcinoma
13 September 2021 - This marks the first ex-China regulatory filing for tislelizumab, following approval in five indications in China. ...
Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 09 Sep 2021
Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations
9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...