Decision on EU marketing authorisation for this population expected by September 2024
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Heavy bleeding after giving birth is globally a leading cause of death in new mothers
Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
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