Shots: The approval is based on non-inferiority data demonstrating biosimilarity between Nivestym and the reference product, Neupogen (filgrastim) Pfizer has received the US FDA’s fourth approvals for its biosimilar including […]readmore
Tags : receives
Shots: The approval is based on 12 clinical trials results assessing TPOXX (tecovirimat) in 700 patients, demonstrating no adverse effects ’ TPOXX (tecovirimat) receives 17-0 votes from FDA’s Antimicrobial Drug […]readmore
Shots: The approval is based on P-III EPIC (Evaluating Plazomicin in cUTI) study results assessing Zemdri (plazomicin, IV) vs Meropenem in 388 patients with cUTI including pyelonephritis aged ≥18 yrs. […]readmore
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 Dravet syndrome aged ≥ 2yrs. The study […]readmore
Regulatory
Uncategorized
Medicines Development for Global Health’s (MDGH) Moxidectin Receives FDA Approval
Shots: The approval is based on two clinical studies results assessing Moxidectin vs SoC Ivermectin in patients with river blindness aged ≥ 12 yrs. The study resulted in meeting 1EPswith […]readmore
Regulatory
Eli Lilly’s Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active
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 one or more TNF inhibitor therapies P-III […]readmore
Biosimilars
Regulatory
Sandoz’s Zessly (infliximab) Receives EU Approval for Gastroenterological, Rheumatological And
Shots: The approval is based on non-inferiority and P-III REFLECTIONS B537-02 study results assessing Zessly vs reference drug and demonstrated meeting 1EPs with safety, efficacy and quality Zessly is 3rd […]readmore
Shots: The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase-pqpz, 20mg qd or 40mg qd) in patients in ratio (2:1) with high level of phenylalanine (Phe) The […]readmore
Shots: The approval is based on five studies assessing Lokelma vs PBO in patients with hyperkalaemia The study resulted in onset of action was at 1.0 hour and the median […]readmore
Shots: The approval is based on P-IIIb LIBERTY (NCT03096834) study results assessing Aimovig (140mg) vs PBO for duration of 12 weeks The study resulted in 50% reduction of monthly migraine […]readmore