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EC expands Astellas` Xtandi label indication in prostate cancer
Astellas Pharma has received the European Commission (EC) approval for the use of Xtandi (enzalutamide) in an additional treatment setting…
EC approves AstraZeneca`s Voydeya as add-on treatment for PNH
The European Commission has approved AstraZeneca’s Voydeya (danicopan) as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) for the…
Medicure Receives US FDA Fast Track Designation For MC-1 For PNPO Deficiency
Medicure, a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the…
Roche’s Alecensa wins FDA approval for ALK-positive NSCLC
Roche has received the US Food and Drug Administration (FDA) approval for Alecensa (alectinib) for patients with anaplastic lymphoma kinase…
FDA approves SC delivery of Takeda`s Entyvio for Crohn`s disease
Takeda has received the US Food and Drug Administration (FDA) approval for the subcutaneous (SC) administration of Entyvio (vedolizumab) to…
AskBio’s AB-1002 gets FDA fast track status for congestive heart failure
Bayer’s subsidiary Asklepios BioPharmaceutical (AskBio) has received fast track designation from the US Food and Drug Administration (FDA) for the…
Lilly’s tirzepatide improves OSA symptoms in two Phase 3 studies
Eli Lilly and Company (Lilly) said that its weight loss drug tirzepatide injection has reduced the severity of obstructive sleep…
GSK says Shingrix continues to provide high protection against shingles for 11 years
GSK said that its Shingrix (Recombinant Zoster Vaccine or RZV) has provided high protection against shingles for over a decade…
Sentynl gets UK MHRA’s approval for Nulibry to treat MoCD Type A
Sentynl Therapeutics has secured authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) of Nulibry (fosdenopterin) for Injection…
AstraZeneca says Imfinzi combo doubles OS rate in late-stage BTC trial
AstraZeneca said that Imfinzi (durvalumab) in combination with standard-of-care chemotherapy doubled the overall survival (OS) rate at three years for…