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RSS FeedPosted by Michael Wonder on 28 Jun 2021
AskBio receives FDA fast track designation for LION-101, a novel investigational AAV gene therapy for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
28 June 2021 - LGMD2I/R9 is a rare form of muscular dystrophy with no approved therapies. ...
Posted by Michael Wonder on 28 Jun 2021
SNDX-5613 granted FDA fast track designation for the treatment of relapsed/refractory acute leukemias
28 June 2021 - Syndax Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to SNDX-5613 for the ...
Posted by Michael Wonder on 28 Jun 2021
Technegas receives complete response letter from the US FDA - requirement to address outstanding technical elements
28 June 2021 - Cyclopharm announces that the US FDA has provided a complete response letter for the new drug application ...
Posted by Michael Wonder on 28 Jun 2021
InnoCare announces breakthrough therapy designation of orelabrutinib by US FDA for treatment of relapsed or refractory mantle cell lymphoma
28 June 2021 - InnoCare Pharma announced today that the U.S. FDA has granted breakthrough therapy designation to its Bruton's ...
Posted by Michael Wonder on 28 Jun 2021
Eagle Pharmaceuticals announces FDA maintains prioritisation of ANDA for vasopressin
24 June 2021 - Assigned GDUFA date of 15 December 2021, and expects commercial launch prior to year-end. ...
Posted by Michael Wonder on 27 Jun 2021
Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US
26 June 2021 - New PDUFA action date for Brixadi set for 15 December 2021. ...
Posted by Michael Wonder on 26 Jun 2021
AbbVie provides update regarding Rinvoq (upadacitinib) in psoriatic arthritis and ankylosing spondylitis in the U.S.
25 June 2021 - AbbVie today announced that the U.S. FDA has informed the company that the FDA will not ...
Posted by Michael Wonder on 26 Jun 2021
Mirati Therapeutics' adagrasib receives breakthrough therapy designation from U.S. FDA for patients with advanced non-small cell lung cancer harbouring the KRASG12C mutation
24 June 2021 - Mirati Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to adagrasib for ...
Posted by Michael Wonder on 25 Jun 2021
Aquestive Therapeutics resubmits new drug application for Libervant (diazepam) buccal film
24 June 2021 - Anticipates FDA PDUFA goal date in late 2021. ...
Posted by Michael Wonder on 25 Jun 2021
Rivaroxaban application submitted to U.S. FDA for approval to treat VTE and to prevent VTE in children
23 June 2021 - Application seeks two paediatric indications, including an age-appropriate new weight-based oral suspension formulation. ...
Posted by Michael Wonder on 24 Jun 2021
ALS association wants more commitment from the FDA
24 June 2021 - In a response letter to the ALS Association, the U.S. FDA has recognised the unmet therapeutic ...
Posted by Michael Wonder on 24 Jun 2021
Alnylam announces U.S. FDA acceptance of new drug application for investigational vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis
24 June 2021 - PDUFA date set for 14 April 2022. ...
Posted by Michael Wonder on 24 Jun 2021
Biogen expects slow Alzheimer’s drug uptake, may reset price
24 June 2021 - Company faces uproar over $56,000 a year price tag for Aduhelm. ...
Posted by Michael Wonder on 24 Jun 2021
Santen receives FDA approval for Verkazia (cyclosporin 0.1% ophthalmic emulsion) for the treatment of vernal keratoconjunctivitis in children and adults
24 June 2021 - Santen today announced that the U.S. FDA has approved Verkazia (cyclosporin 0.1% ophthalmic emulsion eye drops) for ...
Posted by Michael Wonder on 24 Jun 2021
Lilly's donanemab receives U.S. FDA's breakthrough therapy designation for treatment of Alzheimer's disease
24 June 2021 - The U.S. FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's ...