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RSS FeedPosted by Michael Wonder on 15 Nov 2021
Rhythm Pharmaceuticals announces FDA acceptance for filing and priority review of supplemental new drug application for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
15 November 2021 - FDA sets PDUFA goal date of 16 March 2022. ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...
Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label ...
Posted by Michael Wonder on 15 Nov 2021
Wegovy recommended for approval for the treatment of obesity by the European regulatory authorities
11 November 2021 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 13 Nov 2021
Health Canada authorises the use of the Moderna Spikevax COVID-19 vaccine as a booster shot
12 November 2021 - Health Canada has authorised the use of the Moderna Spikevax COVID-19 vaccine as a booster shot. ...
Posted by Michael Wonder on 13 Nov 2021
FDA approves treatment for rare blood disease
12 November 2021 - Treatment is first FDA approved option patients can take regardless of previous therapies. ...
Posted by Michael Wonder on 13 Nov 2021
Biden nominates Califf as FDA chief
12 November 2021 - President Joe Biden on Friday nominated former Commissioner Robert Califf to lead the FDA, in a ...
Posted by Michael Wonder on 13 Nov 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in children with cystic fibrosis ages 6 through 11
12 November 2021 - If approved, more than 1,500 children would be eligible for a medicine that can treat the ...
Posted by Michael Wonder on 13 Nov 2021
Highlights from CHMP 8-11 November 2021 meeting
12 November 2021 - EMA’s CHMP recommended eleven medicines for approval at its November 2021 meeting. ...
Posted by Michael Wonder on 13 Nov 2021
Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements
12 November 2021 - On 28 April 2021, the US FDA announced that it “issued its first Notice of Non-compliance to ...
Posted by Michael Wonder on 12 Nov 2021
First in class medicine recommended for treatment of rare blood vessel inflammation
12 November 2021 - EMA has recommended granting a marketing authorisation in the European Union for Tavneos (avacopan), a first in ...
Posted by Michael Wonder on 11 Nov 2021
FDA touts success and challenges in biosimilar development
10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...
Posted by Michael Wonder on 11 Nov 2021
Health tech questions await next FDA chief
10 November 2021 - Twenty months into the pandemic, the FDA remains consumed with vital decisions on coronavirus vaccines and treatments. ...
Posted by Michael Wonder on 11 Nov 2021
US FDA accepts supplemental new drug application and grants priority review for Jardiance for adults with heart failure independent of left ventricular ejection fraction
11 November 2021 - If approved, Jardiance would be the first clinically proven treatment for adults across the full spectrum ...
Posted by Michael Wonder on 11 Nov 2021
Valneva receives EU deal for COVID jab, and seeks apology from UK
11 November 2021 - French vaccine manufacturer, Valneva, has announced that it has won EU approval to supply up to 60 ...