The European Medicines Agency has OKd two new H5N1 jabs, including a pandemic preparedness vaccine intended for use only if a flu pandemic is declared. Eight other products are also heading for EU-wide approval.

The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.

Developers of three new drugs, including two orphan medicines, that are nearing the final stages of their EU regulatory review cycle could be asked to explain why the European Medicines Agency should recommend approval of their products.

Linking up with Germany’s Neuraxpharm to sell the multiple sclerosis drug Briumvi in Europe and elsewhere has gone down badly with investors but the bashing that TG Therapeutics’ shares has taken seems excessive.