Shots: The approval is based on P-III Archway study evaluates Susvimo (100 mg/mL, IV, q3mos.) via ocular implant vs ranibizumab (0.5mg, IV) in 415 patients with wet AMD prior responded […]readmore
Tags : approval
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. […]readmore
Regulatory
Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Low-Dose Tablet Receives the US FDA’s
Shots: The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with HIV-1 who are virologically suppressed […]readmore
Biosimilars
Regulatory
Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed […]readmore
Shots: The approval is based on P-III IMpower010 study Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 […]readmore
Shots: The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as […]readmore
Shots: The approval is based on P-III IKEMA study assessing Sarclisa in combination with carfilzomib and dexamethasone (Kd) in 302 patients with relapsed MM who have received 1 to 3 […]readmore
Shots: The approval is based on the P-III clinical trial program including Measure Up 1/2/AD Up that evaluates the efficacy & safety of Rinvoq (qd) as monothx. with TCS vs […]readmore
Shots: The approval is based on the P-III ADVOCATE trial that evaluates Tavneos in 330 patients with ANCA-associated vasculitis across 20 countries. Patients were randomized to receive either rituximab or […]readmore
Shots: ViiV Healthcare has reported a regulatory submission to the US FDA for the approval of a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir & lamivudine. […]readmore