Shots: The approval is based on filled sNDA by Teva to the US FDA assessing ProAir Digihaler in COPD and asthma patients treating bronchospasm The electronic device with built in […]readmore
Tags : receives
Shots: Vaxelis a hexavalent combination vaccine is approved for the prevention of Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B and Haemophilus influenzae type B in children from 6 wks. to 4 […]readmore
Shots: The expansion approval of age range for ravicti is based on the study assessing safety, efficacy and PK in UCD infants patients aged ≤ 2mos. The study demonstrated safety and […]readmore
Shots: The approval is based on ORIENT-1 study results assessing Tyvyt in patients with 2L+ Hodgkin’s lymphoma The ORIENT-1 study resulted in effective complete response rates for CT + radiotherapy in patients […]readmore
Biosimilars
Regulatory
Alexion’s Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval in Patients with Paroxysmal
Shots: The approval is based on P-III study results assessing of Ultomiris (IV qw, q8w) vs Soliris in 441 patients who were not treated with inhibitors or Soliris with patiparoxysmal […]readmore
Shots: Zydus’s doxycycline hyclate delayed-release tablets has received FDA approval for 75 mg, 100 mg and 150 mg to treat or prevent infections to susceptible bacteria Zydus has also received […]readmore
Regulatory
Servier’s Asparlas (calaspargase pegol-mknl) Receives FDA’s Approval for Acute Lymphoblastic
Shots: The approval is based on study assessing Asparlas (2500 U/m2, IV, q3w) in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL The study resulted in achievement […]readmore
Shots: The approval is based on P-II CITN-09/KEYNOTE-017 study assessing Keytruda in 50 patients with recurrent LA or mMCC who had not received prior systemic therapy P-II CITN-09/KEYNOTE-017 study results: […]readmore
Shots: The approval is based on P-III SOLO-1 trial assessing Lynparza (300 mg bid) as maintenance monothx vs PBO in 391 patients in ratio (2:1) with BRCAm advanced ovarian cancer following first-line Pt-based […]readmore
Shots: The designation is based on P-III clinical trial assessing A4250 in patients with progressive familial intrahepatic cholestasis (PFIC) Albireo to get 10 years of market exclusivity with additional two years on completion of pediatric […]readmore