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RSS FeedPosted by Michael Wonder on 18 Nov 2020
Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 18 Nov 2020
Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia
18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...
Posted by Michael Wonder on 18 Nov 2020
FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...
Posted by Michael Wonder on 18 Nov 2020
Alkermes receives FDA complete response letter related to ALKS 3831 manufacturing records review
17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval. ...
Posted by Michael Wonder on 18 Nov 2020
FDA authorises first COVID-19 test for self-testing at home
17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...
Posted by Michael Wonder on 18 Nov 2020
Pfizer has enough safety data about its coronavirus vaccine and is preparing to submit for FDA authorisation, CEO says
17 November 2020 - Pfizer has accumulated enough safety data on its COVID-19 vaccine and is preparing to file for ...
Posted by Michael Wonder on 18 Nov 2020
Does remdesivir actually work against COVID-19?
17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...
Posted by Michael Wonder on 17 Nov 2020
ViiV Healthcare receives FDA breakthrough therapy designation for investigational, long-acting cabotegravir for HIV prevention
17 November 2020 - ViiV Healthcare today announced that the US FDA has granted breakthrough therapy designation for long-acting, injectable cabotegravir ...
Posted by Michael Wonder on 17 Nov 2020
Sommetrics receives FDA breakthrough device designation for its aerSleep II product to treat sleep apnea
17 November 2020 - Sommetrics today announced its lead sleep apnea product, aerSleep II, has received FDA breakthrough device designation. ...
Posted by Michael Wonder on 17 Nov 2020
Genentech files to block marketing of Centus' bevacizumab biosimilar
18 November 2020 - The reference product rights holder contends that Centus has not provided complete information about its manufacturing ...
Posted by Michael Wonder on 17 Nov 2020
FDA’s ongoing commitment to transparency for COVID-19 EUAs
17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...
Posted by Michael Wonder on 17 Nov 2020
UCB’s Vimpat (lacosamide) now approved by FDA in U.S. for primary generalised tonic-clonic seizures and expanded paediatric use for people living with epilepsy
17 November 2020 - All three Vimpat formulations, including injection for intravenous use, are now indicated for the treatment of partial-onset ...
Posted by Michael Wonder on 17 Nov 2020
Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel
16 November 2020 - Bristol-Myers Squibb today announced that the U.S. FDA has informed the company that its review of ...
Posted by Michael Wonder on 17 Nov 2020
PLx Pharma submits supplemental new drug applications for Vazalore 325 mg and 81 mg to U.S. FDA
16 November 2020 - FDA sets estimated completion review date for the end of February 2021. ...
Posted by Michael Wonder on 17 Nov 2020
Kiniksa announces breakthrough therapy designation granted to vixarelimab for the treatment of pruritus associated with prurigo nodularis
16 November 2020 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation to vixarelimab for the ...