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Mylan has submitted a biologics license application (BLA) for MYL-1401O via the 351(K) pathway. The proposed biosimilar version of trastuzumab is indicated to treat several breast and gastric

The company submitted a supplemental new drug application (sNDA) to teh FDA for Stivarga tablets for the second-line systemic treatment of patients with unresectable hepatocellular carcinoma (uHCC). The drug

Both companies’ products target an abnormal form of the autologous cell surface-associated protein, Mucin 1 (MUC1), which is over-expressed in the majority of known tumor types. Due to

Additional small molecule compounds acting through the same target as LX9211 are also included in the exclusive arrangement.  LX9211 is currently completing IND-enabling studies, with Phase 1 clinical

Acromegaly is a rare endocrine disorder in which the body produces excessive growth hormone, leading to abnormal growth throughout the body over time.  The FDA's Orphan Drug Designation

Cherish, the study assessing Spinraza in later-onset SMA, found that children receiving the drug experienced a highly statistically-significant improvement in motor function compared to those who did not

The company will buy nearly seven million newly issued Aimmune’s common stock shares each priced at $19.20. Both Aimmune and Nestlé Health Science have also agreed to collaborate on

Livatag (doxorubicine Transdrug, a nanoparticle formulation of doxorubicin) is currently being evaluated clinically as a monotherapy in a Phase III ReLive trial for second-line advanced hepatocellular carcinoma (HCC). More

PARP is a naturally-occurring enzyme in the body that repairs damage to DNA in cells. While this repair is a useful process to maintain the integrity of healthy