FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.
GlaxoSmithKline PLC's blockbuster asthma treatment Advair Diskus (fluticasone/salmeterol) will have more time on the market alone now that a near-term headwind has been removed. Mylan NV was expecting US FDA action on its ANDA for a generic version of Advair by June 27, but the agency notified the company that it should expect a complete response letter rather than approval.
Mylan told investors after market close June 13 that it expects to receive a CRL from FDA on the June...
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
Discontinuation of the AML study created concern about potential readthrough to a pivotal MDS trial, but the company and analysts pointed out differences in the diseases.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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