June, 2018 | PharmaShots

Achaogen’s Zemdri (plazomicin) Receives FDA Approval for Complicated Urinary Tract Infection (cUTI)

June 26, 2018June 18, 2019Shiwani Sharma

Shots: The approval is based on P-III EPIC (Evaluating Plazomicin in cUTI) study results assessing Zemdri (plazomicin, IV) vs Meropenem in 388 patients [Read More...]

GW Pharmaceuticals’ Epidiolex (cannabidiol) Receives FDA Approval for Epilepsy for 2yrs. or older

June 25, 2018June 18, 2019Shiwani Sharma

Shots: The approval is based on three P-III studies results assessing Epidiolex (cannabidiol, PO) vs PBO in 516 patients with Lennox-Gastaut syndrome (LGS) or [Read More...]

Medicines Development for Global Health’s (MDGH) Moxidectin Receives FDA Approval for Onchocerciasis (River Blindness)

June 13, 2018June 18, 2019Shiwani Sharma

Shots: The approval is based on two clinical studies results assessing Moxidectin vs SoC Ivermectin in patients with river blindness aged ≥ 12 [Read More...]

IBRI Signs a License Agreement with Eli Lilly to Access its Fab Phage Display Library

Eli Lilly’s Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active Rheumatoid Arthritis (RA) in Adults

June 6, 2018June 18, 2019Shiwani Sharma

Shots: The approval is based on P-III RA-BEACON study results assessing Olumiant vs PBO in 527 patients with inadequate response or intolerance to [Read More...]