FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.
It doesn't appear there is going to be a quick fix to get Mylan NV's generic version of GlaxoSmithKline PLC's AdvairDiskus (fluticasone/salmeterol) to market. President Rajiv Malik told investors May 10 that the US FDA's complete response to its ANDA for an interchangeable version of Advair was deemed a "major CRL."
The company's first quarter sales and earnings release was the first chance investors have had to hear publicly from management...
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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