We are working closely with the FDA to bring this additional Nubeqa treatment option to patients as soon as possible.” Bayer’s 2023 financial report detailed how therapy generated €869m ($ ...

Bayer BAYRY announced that the FDA has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide). The sNDA is seeking label expansion of Nubeqa in combination with androgen ...

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 ...

Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil ...

Finance, Bayer’s market cap has fallen more than ... streamlining structures in the pharma division accelerated the launch of Nubeqa - a drug that’s already generated over $1 billion USD.

the upside from Nubeqa and Kerendia may be slower or weaker than expected - setting up for a negative risk reward. Looking beyond 2025, the picture for Bayer is expected to remain very challenged.

These launches are what Oelrich called “must-win battles” at Bayer as the Xarelto loss of exclusivity reaches “full swing” in ...

Bayer recently submitted an application to the ... in addition to filings in the U.S. and the EU earlier in 2024. NUBEQA achieved global blockbuster status in September 2024 after crossing the ...

2024 Bayer said on Monday that it has applied to the EU's drugs regulator for the use of Nubeqa, also known as darolutamide, in combination with androgen deprivation therapy. Bayer applies for ...

Bayer recently submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for this third indication for darolutamide in addition to ...