Approvals

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.

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

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.

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

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.

The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

Lynkuet will compete with Astellas's Veozah/Veoza

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

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.