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Cirmtuzumab is an investigational anti-ROR1 monoclonal antibody being evaluated in clinical trials in patients with MCL, CLL and HER2-negative breast cancer. Under the Orphan Drug Act, the FDA

The approval has been granted for Daurismo, a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, to treat newly diagnosed AML in adult

Some patients with AHRF can progress to a more severe form of the disease called acute respiratory distress syndrome (ARDS). ARDS, which is associated with lung inflammation leading

Duvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which is yet to be approved for any indication anywhere else in the world with the exception of Japan.

The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95%

Phesgo is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, which is administered by subcutaneous injection in combination with intravenous (IV) chemotherapy. Phesgo is said

Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based

Piramal Pharma comprises four businesses, which includes a contract development and manufacturing (CDMO) business called Piramal Pharma Solutions. The pharma group also runs a complex hospital generics business

The company expects to complete the NDA submission in the 4th quarter of 2020. “Following receipt of Breakthrough Therapy, Fast Track, and Orphan Designations, the initiation of the