Shots: The positive opinion recommendation follows the study assessing arginine and lysine of same content as LysaKare, evaluating its safety and efficacy The EC will review CHMP’s opinion with its […]readmore
Shots: Zynquista’s CHMP recommendation is based on P-III TANDEM study assessing Zynquista (200mg &400mg) vs insulin in 3,000 patients with T1D mellitus. The study resulted in reduction in blood sugar […]readmore
Shots: The positive opinion is based on P-III KEYNOTE-407 trials results assessing Keytruda + CT (carboplatin/paclitaxel/nab-paclitaxel) vs CT monothx. in patients with msq NSCLC The P-III KEYNOTE-407 trials resulted in […]readmore
Shots: The expansion approval is based on the CA180-372 (NCT01460160) P-II study results assessing Sprycel (qd, 60 mg/m @24 mos.) + CT in 78 patients with Ph+ ALLaged 2 to […]readmore
Shots: The CHMP (EMA) recommendation is based on P-II CA180-372 (NCT01460160) study assessing Sprycel + CT in pediatric patients with newly diagnosed +ve acute lymphoblastic leukemia (ALL) Sprycel received the US FDA’s and EU’s […]readmore
Shots: The combination therapy recommendation of Kisqali plus endocrine therapy is based on results of P-III MONALEESA-7 and MONALEESA-3 trials assessing Kisqali vs endocrine therapy alone in women with HR+/HER2- […]readmore
Shots: CHMP recommendation is based on the results of P-III CheckMate-214 study assessing Opdivo 3 mg/kg (q3w @four doses, q2w) + Yervoy 1 mg/kg vs sunitinib (50 mg qd @four […]readmore
Shots: The CHMP recommendation will be reviewed by EU with expected closure in H2’18. In 2017, FDA approved Ogivri a novel biosimilar to Herceptin with additional regulatory approval in 35 […]readmore
Shots: Post FDA approval in H1’18, CHMP has recommended Fulphila based on its biosimilarity data assessing Fulphila vs Neulasta (Amgen’s biosimilar) in patients with Neutropenia and demonstrated non-inferiority data in […]readmore
Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, […]readmore
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