Approvals

The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.

Coartem Baby to be rolled out in eight African countries in the autumn.

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Rumor mill suggests a $15bn licensing deal for ivonescimab is in the offing.

Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

As Biocon Biologics picks up the latest approvals in Europe for its Stelara biosimilar, Blake Leitch, the firm’s head of Europe, talks to Generics Bulletin about what lies ahead for Biocon and for biosimilars more widely in the region – including tackling the “biosimilar void”.

Canada will welcome its first Eylea off-patent rival in July, as Biocon Biologics celebrates the commercialization of its 10th biosimilar worldwide.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.