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RSS FeedPosted by Michael Wonder on 01 Mar 2021
Avadel Pharmaceuticals announces FDA acceptance of new drug application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy
1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021. ...
Posted by Michael Wonder on 01 Mar 2021
CorMedix receives complete response letter from FDA for DefenCath catheter lock solution
1 March 2021 - CorMedix announced today that the US FDA cannot approve the new drug application for DefenCath (taurolidine/heparin catheter ...
Posted by Michael Wonder on 01 Mar 2021
Athenex receives FDA complete response letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
1 March 2021 - Athenex today announced that the U.S. FDA has issued a complete response letter for the company’s ...
Posted by Michael Wonder on 01 Mar 2021
Rare Disease Day 2021: FDA shows sustained support of rare disease product development during the public health emergency
1 March 2021 - Rare Disease Day is a time to reflect on both the progress that has been made, and ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 01 Mar 2021
FDA authorises first robotically assisted surgical device for performing transvaginal hysterectomy
1 March 2021 - The U.S. FDA has authorised marketing of the Hominis Surgical System, a new robotically-assisted surgical device that ...
Posted by Michael Wonder on 01 Mar 2021
FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
26 February 2021 - Today the FDA granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone ...
Posted by Michael Wonder on 01 Mar 2021
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for retifanlimab as a treatment for patients with squamous cell anal carcinoma
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...
Posted by Michael Wonder on 01 Mar 2021
FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine
25 February 2021 - Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution. ...
Posted by Michael Wonder on 01 Mar 2021
EMA accepts Pfizer's marketing authorisation application for its investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age or older
26 February 2021 - If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 01 Mar 2021
Johnson & Johnson COVID-19 vaccine authorised by U.S. FDA for emergency use - first single shot vaccine in fight against global pandemic
27 February 2021 - Johnson & Johnson today announced that the U.S. FDA has issued emergency use authorisation for its single-dose ...
Posted by Michael Wonder on 01 Mar 2021
Health Canada approves AstraZeneca's COVID-19 vaccine
26 February 2021 - Canada's regulator estimates vaccine's efficacy at 62.1 per cent. ...
Posted by Michael Wonder on 28 Feb 2021
EMA accepts marketing application for somatrogon to treat paediatric patients with growth hormone deficiency
26 February 2021 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 28 Feb 2021
GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer
26 February 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending dostarlimab, an anti-programmed ...
Posted by Michael Wonder on 27 Feb 2021
FDA issues emergency use authorisation for third COVID-19 vaccine
27 February 2021 - Action advances fight against COVID-19, follows comprehensive evaluation of available safety, effectiveness and manufacturing quality information by ...