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RSS FeedPosted by Michael Wonder on 11 Feb 2023
State of the Union highlights America’s awkward conversation on financing the development of new medicines
9 February 2023 - Science, medicine, health care, and paying for medicines featured prominently in President Joe Biden’s State of ...
Posted by Michael Wonder on 10 Feb 2023
FDA approves Pfizer's supplemental new drug application for Cibinqo (abrocitinib)
10 February 2023 - Label expansion for Cibinqo provides new systemic oral option for adolescents (12 to <18 years) with ...
Posted by Michael Wonder on 10 Feb 2023
Phathom Pharmaceuticals provides regulatory updates
9 February 2023 - Phathom Pharmaceuticals today announced regulatory updates for its approved products, Voquenza Triple Pak and Voquenza Dual Pak, ...
Posted by Michael Wonder on 10 Feb 2023
A new Alzheimer's drug gave patients hope. Millions can't get it.
10 February 2023 - Jay Reinstein, a former assistant city manager in Fayetteville, NC who was diagnosed with Alzheimer’s disease ...
Posted by Michael Wonder on 09 Feb 2023
FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
9 February 2023 - Today, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) for adult patients with mismatch repair deficient (dMMR) recurrent ...
Posted by Michael Wonder on 09 Feb 2023
Nexus Pharmaceuticals receives FDA approval for tirofiban hydrochloride injection
9 February 2023 - Nexus Pharmaceuticals announced that it has received US FDA approval for tirofiban hydrochloride injection in 5 ...
Posted by Michael Wonder on 09 Feb 2023
Eylea (aflibercept) injection approved as the first pharmacological treatment for preterm infants with retinopathy of prematurity by the FDA
8 February 2023 - Eylea now approved to treat five retinal conditions caused by ocular angiogenesis. ...
Posted by Michael Wonder on 08 Feb 2023
Appili Therapeutics announces that FDA accepts the ATI-1501 NDA
8 February 2023 - ATI-1501, liquid oral reformulation of the antibiotic metronidazole, receives PDUFA action date of 23 September 2023. ...
Posted by Michael Wonder on 08 Feb 2023
Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence
7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...
Posted by Michael Wonder on 07 Feb 2023
Aldeyra Therapeutics announces FDA acceptance of new drug application for reproxalap for the treatment of dry eye disease
7 February 2023 - PDUFA date is 23 November 2023. ...
Posted by Michael Wonder on 06 Feb 2023
Sage Therapeutics and Biogen announce FDA accepts filing of new drug application and grants priority review of zuranolone in the treatment of major depressive disorder and post-partum depression
6 February 2023 - Zuranolone is being evaluated as a potential 14 day, rapid acting, once daily, oral medication to treat ...
Posted by Michael Wonder on 06 Feb 2023
Endogena Therapeutics receives US FDA fast track designation for EA-2353 for the treatment of retinitis pigmentosa
6 February 2023 - Endogena Therapeutics announced today that the US FDA has designated the investigation of EA-2353 for the treatment ...
Posted by Michael Wonder on 06 Feb 2023
Sandoz biologics license application for proposed biosimilar denosumab accepted by US FDA
6 February 2023 - Submission supported by comprehensive analytical and clinical data package. ...
Posted by Michael Wonder on 04 Feb 2023
US FDA approves Takeda’s Takhyzro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
3 February 2023 - Approval supported by extrapolation of efficacy data from the Phase 3 HELP study with additional data from ...
Posted by Michael Wonder on 03 Feb 2023
Medicare may test policy of paying less for accelerated approval drugs
31 January 2023 - Medicare official hinted Tuesday that Medicare might test a policy of paying less for drugs that ...