Wird geladen...

Advertisement

Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

RTTNews | vor 719 Tagen

Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).

The review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.

In addition, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled.

The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.

Tags: AMGN

read more

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...

RTTNews | vor 563 Tagen

Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs

Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs

Amgen, Inc. (AMGN) announced Monday the opening of its manufacturing site in Central Ohio, the newest in its global operations network and the most advanced facility to date.

RTTNews | vor 657 Tagen

Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4

Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4

Amgen (AMGN) and Horizon Therapeutics plc (HZNP) announced Friday the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's $27.8 billion acquisition of Horizon.

RTTNews | vor 835 Tagen

Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

RTTNews | vor 1209 Tagen

Singapore Stock Market May Be Stuck In Neutral On Monday

Singapore Stock Market May Be Stuck In Neutral On Monday

The Singapore stock market has moved higher in two straight sessions, improving almost 75 points or 1.7 percent along the way. The Straits Times Index now sits just above the 4,580-point plateau although it may spin its wheels on Monday.

RTTNews | vor 1Std 28 Minuten

BoJ Tankan: Large Manufacturing Index Ticks Higher In Q4

BoJ Tankan: Large Manufacturing Index Ticks Higher In Q4

Large manufacturing in Japan accelerated slightly in the fourth quarter of 2025, the Bank of Japan's quarterly Tankan Survey of business sentiment showed on Wednesday with a diffusion index score of +15.

RTTNews | vor 1Std 32 Minuten

New Zealand Performance Of Services Index Sinks In November - BusinessNZ

New Zealand Performance Of Services Index Sinks In November - BusinessNZ

The services sector in New Zealand continued to contract in November, and at a faster rate, the latest survey from Business New Zealand revealed on Monday with a Performances of Services Index score of 46.9.

RTTNews | vor 1Std 44 Minuten

Malaysia Bourse Expected To Run Out Of Steam

Malaysia Bourse Expected To Run Out Of Steam

The Malaysia stock market has moved higher in two straight sessions, collecting more than 25 points of 1.7 percent along the way. The Kuala Lumpur Composite Index now sits just beneath the 1,640-point plateau although the rally may stall on Monday.

RTTNews | vor 1Std 58 Minuten

Geschäftsbedingungen | Datenschutz | Sitemap | Site Map Calendar

© 2025 Myfxbook Ltd. Alle Rechte vorbehalten.

WARNUNG VOR HOHEM RISIKO: Der Devisenhandel birgt ein hohes Risiko, das möglicherweise nicht für alle Anleger geeignet ist. Der Einsatz von Leverage schafft zusätzliches Risiko und Verlustgefahr. Bevor Sie sich für den Devisenhandel entscheiden, sollten Sie Ihre Anlageziele, Ihr Erfahrungsniveau und Ihre Risikotoleranz sorgfältig prüfen. Sie könnten Ihre ursprüngliche Investition teilweise oder ganz verlieren. Investieren Sie kein Geld, das Sie sich nicht leisten können, zu verlieren. Informieren Sie sich über die mit dem Devisenhandel verbundenen Risiken und lassen Sie sich von einem unabhängigen Finanz- oder Steuerberater beraten, wenn Sie Fragen haben. Alle Daten und Informationen werden ausschließlich zu Informationszwecken bereitgestellt und sind nicht für Handelszwecke oder Beratung gedacht. Die vergangene Performance ist kein Indikator für zukünftige Ergebnisse.