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RSS FeedPosted by Michael Wonder on 19 Oct 2020
Octapharma announces FDA approval of updated Nuwiq Prescribing Information to include immunogenicity data in previously untreated patients
19 October 2020 - Octapharma is pleased to announce that the U.S. FDA has approved an updated Prescribing Information for Nuwiq, ...
Posted by Michael Wonder on 19 Oct 2020
Neurelis announces FDA approval of extended expiration dating for Valtoco (diazepam nasal spray)
19 October 2020 - Neurelis today that the U.S. FDA has granted extended expiration dating for the company's lead product, Valtoco ...
Posted by Michael Wonder on 19 Oct 2020
U.S. Food and Drug Administration accepts for priority review applications for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in advanced renal cell carcinoma
19 October 2020 - U.S. Food and Drug Administration assigned a target action date of 20 February 2021. ...
Posted by Michael Wonder on 19 Oct 2020
Versantis receives FDA rare paediatric disease designation for VS-01 for the treatment of urea cycle disorders
19 October 2020 - Versantis today announced that the U.S. FDA has granted a rare paediatric disease designation to its lead ...
Posted by Michael Wonder on 19 Oct 2020
AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) in atopic dermatitis
19 October 2020 - In three pivotal Phase 3 studies, Rinvoq met co-primary and all secondary endpoints in adult and adolescent ...
Posted by Michael Wonder on 18 Oct 2020
Pfizer to seek FDA approval for COVID-19 vaccine in November
16 October 2020 - US group and German partner BioNTech prepare to submit trial results next month. ...
Posted by Michael Wonder on 17 Oct 2020
Venclexta (venetoclax) receives FDA full approval for acute myeloid leukaemia
16 October 2020 - The FDA approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is ...
Posted by Michael Wonder on 15 Oct 2020
Testing requirements are likely slowing biosimilar entries in the US
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
Posted by Michael Wonder on 15 Oct 2020
Scynexis announces submission of new drug application to the U.S. FDA for oral ibrexafungerp for the treatment of vaginal yeast infection
15 October 2020 - NDA submission is supported by positive data from two Phase 3 studies (VANISH Program) in women with ...
Posted by Michael Wonder on 15 Oct 2020
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult patients with relapsed or refractory classical Hodgkin lymphoma
15 October 2020 - Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory classic Hodgkin lymphoma ...
Posted by Michael Wonder on 15 Oct 2020
Taysha Gene Therapies receives rare paediatric disease designation and orphan drug designation for TSHA-102 as a treatment for Rett syndrome
14 October 2020 - Program leverages novel miRARE platform technology used to control transgene expression on a cellular basis. ...
Posted by Michael Wonder on 14 Oct 2020
FDA approves first treatment for Ebola virus
14 October 2020 - Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three ...
Posted by Michael Wonder on 14 Oct 2020
U.S. FDA accepts Biohaven's supplemental new drug application of Nurtec ODT for the preventive treatment of migraine
14 October 2020 - Acceptance marks critical milestone in Biohaven's efforts to develop Nurtec ODT as a unique dual therapy for ...
Posted by Michael Wonder on 14 Oct 2020
Harmony Biosciences receives FDA approval for expanded use of Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy
13 October 2020 - Wakix is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult ...
Posted by Michael Wonder on 14 Oct 2020
Bayer submits supplemental new drug application to the FDA for intrauterine device Mirena (levonorgestrel releasing intrauterine system) 52 mg
14 October 2020 - Application seeks to extend duration of use up to seven years for Mirena. ...