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RSS FeedPosted by Michael Wonder on 24 Jan 2023
Fabre-Kramer Pharmaceuticals announces FDA acceptance of NDA resubmission as complete response and assignment of PDUFA regulatory action date
24 January 2023 - Submission of Exxua (gepirone hydrochloride), a novel targeted single serotonin receptor agonist for treatment of major ...
Posted by Michael Wonder on 24 Jan 2023
Verrica Pharmaceuticals announces resubmission of new drug application for VP-102 for the treatment of molluscum contagiosum
24 January 2023 - Potential first FDA approved therapy for treatment of molluscum contagiosum. ...
Posted by Michael Wonder on 23 Jan 2023
Blueprint Medicines announces FDA acceptance of supplemental new drug application for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis
23 January 2023 - FDA grants priority review and sets PDUFA action date of 22 May 2023. ...
Posted by Michael Wonder on 20 Jan 2023
US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
20 January 2023 - The supplemental new drug application is based on results from the landmark EMPA-KIDNEY Phase 3 trial, which ...
Posted by Michael Wonder on 20 Jan 2023
Opiant Pharmaceuticals announces FDA acceptance and priority review of NDA for OPNT003, nasal nalmefene, for opioid overdose
19 January 2023 - FDA sets PDUFA date of 22 May 2023. ...
Posted by Michael Wonder on 20 Jan 2023
US FDA issues complete response letter for accelerated approval of donanemab
19 January 2023 - Complete response letter based on limited number of patients with 12 month drug exposure data in the ...
Posted by Michael Wonder on 19 Jan 2023
FDA accepts Intercept’s new drug application for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH
19 January 2023 - PDUFA target action date set for 22 June 2023. ...
Posted by Michael Wonder on 12 Jan 2023
Eton Pharmaceuticals announces FDA acceptance of NDA response for dehydrated alcohol injection
11 January 2023 - Application assigned a PDUFA date of 27 June 2023. ...
Posted by Michael Wonder on 09 Jan 2023
US FDA issues a CRL for the biologics license application for insulin-R
7 January 2023 - The US FDA has issued a complete response letter for the biologics license application for the insulin-R ...
Posted by Michael Wonder on 09 Jan 2023
Krystal Biotech announces FDA’s 3 month extension of BLA PDUFA date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa
9 January 2023 - Krystal Biotech today announced that on 5 January 2023, the US FDA notified the Company that ...
Posted by Michael Wonder on 09 Jan 2023
Santhera and ReveraGen announce FDA acceptance of new drug application for vamorolone in Duchenne muscular dystrophy
9 January 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce that the US FDA has accepted the new drug application for ...
Posted by Michael Wonder on 08 Jan 2023
Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia
7 January 2023 - The FDA target date (PDUFA date) for completion of the review is 10 May 2023. ...
Posted by Michael Wonder on 07 Jan 2023
Eisai submits supplemental biologics license application to FDA for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease
7 January 2023 - Submission for traditional approval follows FDA accelerated approval of Leqembi on the same day, and is ...
Posted by Michael Wonder on 07 Jan 2023
Novan submits new drug application to the US FDA for berdazimer (SB206) 10.3% topical gel for the treatment of molluscum contagiosum
6 January 2023 - Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and ...
Posted by Michael Wonder on 07 Jan 2023
FDA grants priority review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
5 January 2023 - Results from the pivotal Phase 1/2 NP30179 study showed glofitamab induced durable response rates in people with ...