Viatris announces FDA acceptance of NDA for fast-acting meloxicam
The FDA set a PDUFA goal date of Dec. 27, 2026 for the non-opioid acute pain treatment.
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Global healthcare company
viatris.comLast updated
In short: Viatris reported strong 2026 financial results, issued €650 million in senior notes, and secured several FDA regulatory milestones and settlements.
The FDA set a PDUFA goal date of Dec. 27, 2026 for the non-opioid acute pain treatment.
Total revenues reached $3.5 billion, up 8% reported. Adjusted EBITDA hit $1.0 billion, up 10% operationally. Reaffirms full-year guidance.
Theodora Mistras departs; Paul Campbell named interim CFO effective May 8, 2026.
Six abstracts on Phase 3 efficacy, safety, adhesion, and pharmacokinetics will be presented at the 2026 ACOG meeting. FDA NDA review is ongoing with PDUFA date July 30, 2026.
An announcement from Viatris ( (VTRS)) is now available. On June 12, 2026, Viatris Inc. entered into an underwriting agreement with a syndicate of banks...
The said operations include a total of six large-scale API manufacturing facilities, three each in Vizag and Hyderabad, an ...
A Viatris Inc. shareholder sued the pharmaceutical company’s directors and executives, alleging they failed to oversee manufacturing practices at a facility in India faulted by...
Viatris Inc., based in Pennsylvania, is a specialty and generic drug company formed in 2020 through the combination of Pfizer's Upjohn business and Mylan N.V...
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