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RSS FeedPosted by Michael Wonder on 27 Jun 2021
BioMarin receives positive CHMP opinion in Europe for vosoritide for the treatment of children with achondroplasia from age 2 until growth plates close
25 June 2021 - Temporary Authorization for Use (ATU) granted in France to allow access and reimbursement of vosoritide to begin ...
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 27 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for anti-BCMA CAR T cell therapy Abecma (idecabtagene vicleucel) for relapsed and refractory multiple myeloma
25 June 2021 - Recommendation for approval based on results from pivotal KarMMa study. ...
Posted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...
Posted by Michael Wonder on 27 Jun 2021
Highlights from 21-24 June CHMP meeting
25 June 2021 - EMA’s CHMP recommended eight medicines for approval at its June 2021 meeting. ...
Posted by Michael Wonder on 27 Jun 2021
In an about face, Health Canada allows a controversial rare disease drug back on the market
26 June 2021 - In yet another twist in a complicated tale, Health Canada has reinstated approval of a rare ...
Posted by Michael Wonder on 26 Jun 2021
CHMP recommends approval of Rinvoq (upadacitinib) for the treatment of atopic dermatitis
25 June 2021 - Positive opinion based on three global Phase 3 pivotal clinical trials evaluating the safety and efficacy of ...
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 26 Jun 2021
TGA grants third provisional approval to COVID-19 vaccine: Janssen
25 June 2021 - On 25 June 2021, the TGA granted provisional approval to Janssen-Cilag for its COVID-19 vaccine Janssen, ...
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. ...