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European regulator recommends Bavarian Nordic's vaccine for monkeypox

Bio Pharma Dive

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.

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Pfizer’s RSV vaccine wins FDA approval in older adults

Bio Pharma Dive

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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Europe's drug regulator links J&J's vaccine to rare clots as US pause continues

Bio Pharma Dive

The EMA reiterated the vaccine's benefits outweigh its risks but recommended a warning be added to highlight the rare, but serious side effect. Regulators in the U.S. are expected to soon make a similar decision.

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Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators

Bio Pharma Dive

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

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EMA adds allergic reaction warning to Novavax's COVID-19 vaccine

Bio Pharma Dive

The regulator said there have been “a few” spontaneous severe allergic reactions following administration of the vaccine, which was this week authorized in the U.S.

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Vaccine from Medicago, GSK protective against COVID-19 in large study

Bio Pharma Dive

The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.

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FDA panel endorses second shot for adults who received J&J vaccine

Bio Pharma Dive

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.