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RSS FeedPosted by Michael Wonder on 11 Oct 2021
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis
11 October 2021 - Approval represents the first primarily office-based indication for Dextenza. ...
Posted by Michael Wonder on 08 Oct 2021
Janssen submits application seeking U.S. FDA approval of Stelara (ustekinumab) for the treatment of paediatric patients with juvenile psoriatic arthritis
8 October 2021 - Application utilises extrapolation-based strategy across existing breadth of Stelara data in patients living with this chronic inflammatory ...
Posted by Michael Wonder on 08 Oct 2021
Arcutis submits topical roflumilast cream new drug application to FDA for the treatment of adults and adolescents with plaque psoriasis
4 October 2021 - Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of IGA Success and statistically ...
Posted by Michael Wonder on 07 Oct 2021
Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11
8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...
Posted by Michael Wonder on 07 Oct 2021
Mayne Pharma provides FDA update on generic Nuvaring
7 October 2021 - Mayne Pharma has received a complete response letter from the US FDA in relation to its ...
Posted by Michael Wonder on 06 Oct 2021
Acer Therapeutics and Relief Therapeutics announce FDA acceptance for filing of new drug application for ACER-001 to treat urea cycle disorders
6 October 2021 - FDA sets PDUFA target action date of June 5, 2022. ...
Posted by Michael Wonder on 06 Oct 2021
Complete response letter received from FDA
6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...
Posted by Michael Wonder on 06 Oct 2021
Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine
5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...
Posted by Michael Wonder on 05 Oct 2021
Heron Therapeutics announces filing of a supplemental new drug application for significant expansion of Zynrelef indication statement based on successful outcome of FDA type C meeting
4 October 2021 - FDA agreed to the immediate filing of supplemental new drug application to significantly expand the Zynrelef indication ...
Posted by Michael Wonder on 04 Oct 2021
ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir for children living with HIV
4 October 2021 - ViiV Healthcare has announced it has made a regulatory submission to the U.S. FDA for approval of ...
Posted by Michael Wonder on 02 Oct 2021
Omeros provides regulatory update on biologics license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy
1 October 2021 - Omeros Corporation today announced that the U.S. FDA notified the company that, as part of FDA’s on-going ...
Posted by Michael Wonder on 01 Oct 2021
Kite submits supplemental biologics license application to U.S. FDA for earlier use of Yescarta in large B-cell lymphoma
30 September 2021 - Supplemental biologics license application filing based on landmark ZUMA-7 study, the first randomised clinical trial to evaluate ...
Posted by Michael Wonder on 01 Oct 2021
TG Therapeutics submits biologics license application to the U.S. FDA for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
30 September 2021 - TG Therapeutics today announced the submission of a biologics license application to the U.S. FDA requesting approval ...
Posted by Michael Wonder on 30 Sep 2021
Zogenix submits supplemental new drug application for Fintempla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
28 September 2021 - Supplemental new drug application submission is supported by existing clinical data, including positive data from Company’s Phase ...
Posted by Michael Wonder on 29 Sep 2021
U.S. FDA accepts filings for Amicus’ AT-GAA for the treatment of Pompe disease
29 September 2021 - FDA sets PDUFA target action date of 29 May 2022 for the new drug application and 29 ...