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RSS FeedPosted 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 ...
Posted by Michael Wonder on 27 Feb 2021
FDA approves first treatment for molybdenum cofactor deficiency type A
26 February 2021 - Today, the U.S. FDA approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to ...
Posted by Michael Wonder on 26 Feb 2021
Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy treatment with proven efficacy in adults, children and infants two months and older
26 February 2021 - Evrysdi is approved in seven countries, submitted in 30 more. ...
Posted by Michael Wonder on 26 Feb 2021
FDA authorises marketing of novel device to help protect athletes’ brains during head impacts
26 February 2021 - Today, the U.S. FDA authorised marketing of a new device intended to be worn around the neck ...
Posted by Michael Wonder on 26 Feb 2021
Emgality (galcanezumab) now approved for use in Canada for the treatment of episodic cluster headache
25 February 2021 - The first and only anti-CGRP treatment with dual indications. ...
Posted by Michael Wonder on 26 Feb 2021
BioCryst receives positive CHMP opinion for Orladeyo (berotralstat), an oral, once daily therapy to prevent attacks in patients with hereditary angioedema
25 February 2021 - BioCryst Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
Posted by Michael Wonder on 26 Feb 2021
Medexus announces expanded availability of Gleolan in Canada
25 February 2021 - Medexus Pharmaceuticals announced today that it has initiated the commercial launch of Gleolan in Canada, which had ...