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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Nov 2020
HHS Secretary Azar says the FDA will move ‘as quickly as possible’ to clear Moderna and Pfizer’s COVID-19 vaccines
16 November 2020 - There should be enough vaccine doses made by Pfizer and Moderna to inoculate roughly 20 million before ...
Posted by Michael Wonder on 16 Nov 2020
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of PNH
16 November 2020 - FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss ...
Posted by Michael Wonder on 16 Nov 2020
Lupin announces FDA filing acceptance of supplemental new drug application for Solosec (secnidazole) for the treatment of trichomoniasis
16 November 2020 - Lupin Pharmaceuticals announced today that the U.S. FDA has accepted their supplemental new drug application for ...
Posted by Michael Wonder on 16 Nov 2020
CHMP adopted positive opinion for Elzonris (tagraxofusp) for the treatment of blastic plasmacytoid dendritic cell neoplasm
13 November 2020 - The CHMP recommended approval of Elzonris for the first line treatment of adult patients with blastic plasmacytoid ...
Posted by Michael Wonder on 16 Nov 2020
CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2 positive breast cancer
13 November 2020 - Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under ...
Posted by Michael Wonder on 16 Nov 2020
Swissmedic begins rolling review of Moderna’s mRNA vaccine against COVID-19 (mRNA-1273)
13 November 2020 - Moderna completed enrolment of its Phase 3 COVE study of mRNA-1273 on October 22. ...
Posted by Michael Wonder on 16 Nov 2020
The CHMP has adopted a negative opinion for emapalumab in Europe for the treatment of primary HLH
13 November 2020 - Sobi today announced that the CHMP has adopted a negative opinion recommending a refusal of the ...
Posted by Michael Wonder on 16 Nov 2020
Emer Cooke takes office as head of EMA
16 November 2020 - Emer Cooke has begun her mandate as Executive Director of the European Medicines Agency today. ...