Albireo Pharma, a spinout of AstraZeneca, won regulatory approval for the first drug aimed at pruritus in patients with all subtypes of progressive familial intrahepatic cholestasis (PFIC).
The head of the EU drug regulator’s Covid-19 task force said on June 13 that AstraZeneca’s coronavirus vaccine had a favorable risk-benefit profile for all age groups and particularly for those aged over 60.
Europe’s drug regulator on June 11 identified another rare blood condition as a potential side effect of AstraZeneca’s Covid-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.
Ipsen’s New Drug Application (NDA) for palovarotene – an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP) – was accepted by the U.S. Food and Drug Administration.
Europe’s medicines regulator on May 28 backed the use of Pfizer’s Covid-19 vaccine for children as young as 12, paving way for a broader roll-out in the region after similar clearances in the United States and Canada.
Europe’s medicines regulator is reviewing reports of a rare nerve-degenerating disorder in people who received AstraZeneca’s Covid-19 shots, raising fresh questions about potential side effects of the vaccine.
The European Medicines Agency will conduct an accelerated review of Eli Lilly and Co.’s rheumatoid arthritis drug Olumiant for hospitalized Covid-19 patients getting oxygen, the EU agency said on April 29, as the search for treatment options continues.
European countries prepared on April 21 to resume deliveries of Johnson & Johnson’s Covid-19 vaccine and speed up the rollout after Europe’s drug regulator backed the shot.
Johnson & Johnson said on April 20 the company will resume rolling out its Covid-19 vaccine in Europe after the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.
Europe’s drug regulator found a possible link between Johnson & Johnson’s Covid-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.