Shots: The approval is based on non-inferiority data with the reference biologic (Neulasta) showing biosimilarity in terms of safety, efficacy and quality Ziextenzo is a long-lasting form of filgrastim indicated […]readmore
Shots: The approval is based on P-III trial, involving assesment of Luxturna vs control group patients, with inherited retinal disease (caused due to mutation in both copies of the RPE65 […]readmore
Shots: Pelmeg (Pegfilgrastim, Biosimilar) is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic CT for malignancy CHMP recommends Pelmeg based […]readmore
Shots: The approval of Sublocade(qmt) in combination with medication-assisted treatment (MAT) is indicated to treat OUD in adults, using Atrigel delivery system The clinical trials demonstrated, that Injection site reactions […]readmore
Shots: The accelerated approval is based on M14-358 (P-Ib) & M14-387 study (I/II) results assessing Venclexta (400mg qd) + azacitidine & decitabine & Venclexta (600mg qd) + LDAC (low-dose cytarabine) […]readmore
Shots: Post FDA 510(K) approval, Apex Femoral Nailing System has received CE Mark clearance indicated to stimulate bone callus formation Apex Femoral Nailing System has micromotion locking system with anatomic […]readmore
Shots: The approval is based on P-I/II (B7461001) study assessing Lorbrena (100mg, qd) in 215 patients with ALK-positive metastatic NSCLC, who were treated with one or more ALK TKIs The […]readmore
Shots: The approval is based on P-II/III (NCT01818492) study results assessing Gamifant IV in patients with primary HLH, evaluating its safety, efficacy and tolerability The P-II/III study resulted in meeting […]readmore
Shots: The approval is based on the results of two international P-III 108 and 110 study assessing Vemlidy vs Viread in 1,632 patients with HBeAg-negative and HBeAg-positive HBV disease for […]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
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