Amgen announced that the European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.
Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy company, today announces the clearance of the Company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for RP-A501.
Vertex Pharmaceuticals (Europe) has secured approval from the European Commission (EC) for Orkambi (lumacaftor/ivacaftor) to treat of children with cystic fibrosis (CF) aged two to five years old who have two copies of the F508del mutation.
Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company (“Lilly”).
The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing approval from the European Commission (EC) for Erleada (apalutamide) to treat non-metastatic castration-resistant prostate cancer (nmCRPC).
Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia.
Exelixis announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Pfizer’s tafamidis meglumine form (20mg capsule) has secured priority review from the US Food and Drug Administration (FDA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).
UK-based specialty pharma company Diurnal Group said that the US Patent and Trademark Office (USPTO) has granted a second US patent for Chronocort (modified release hydrocortisone).
Ocular Therapeutix is seeking approval from the US Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert) to expand the current indication to include the treatment of ocular inflammation following ophthalmic surgery.
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