Several highly anticipated PDUFA decisions are approaching..👇 Abeona Therapeutics ($Abeona Therapeutics (ABEO.US)$) Asset: Pz-cel (prademagene zamikeracel) PDUFA Date: May 25, 2024 Indication: Recessive dystrophic epidermolysis bullosa (RDEB) Technology: Autologous cell therapy, treatment uses gene transfer to deliver COL7A1 genes into an RDEB patient’s own skin cells then transplanting them back to the patient. Rocket Pharmaceuticals ($Rocket Pharmaceuticals (RCKT.US)$) ...
Rocket Pharmaceuticals股票讨论
美国食品药品监督管理局向rocket pharmaceuticals的Kresladi(Marnetegragene Autotemcel)基因治疗药物发出完整回应信,用于治疗严重脱嗜酸性白细胞粘附缺陷-I,FDA要求提供有限额外CMC信息
$Harmony Biosciences (HRMY.US)$ : WAKIX(吡托利珊)
$施贵宝 (BMY.US)$ : KRAZATI(阿达格拉西布)+ Cetuximab
$argenx SE (ARGX.US)$ : VYVGARt Hytrulo(埃法外噠模特)
$默沙东 (MRK.US)$ 帕替单抗德鲁瑟单抗
$维罗纳制药 (VRNA.US)$ 恩斯非替林(雾化)
$Rocket Pharmaceuticals (RCKT.US)$ 克雷拉迪(马尼特格雷基因自体细胞)
$葛兰素史克 (GSK.US)$ : Arexvy
$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : Elafibranor
$礼来 (LLY.US)$ :Donanemab - AdCom会议 🗓️
$再生元制药公司 (REGN.US)$ :Kevzara(沙利度单抗)
$施贵宝 (BMY.US)$ :Augtyro™(雷博曲替尼)
$杰龙 (GERN.US)$ :Imetelstat
$默沙东 (MRK.US)$ : V116
$安进 (AMGN.US)$ : BLINCYTO(blinatumomab)
$Sarepta Therapeutics (SRPT.US)$ : ELEVIDYS
$默沙东 (MRK.US)$ : KEYTRUDA ...
$施贵宝 (BMY.US)$ : Breyanzi
‣ PDUFA日期:2024年5月31日 (sBLA)
$Moderna (MRNA.US)$ :mRNA-1345
▸ PDUFA日期:2024年5月底(预计)(生物许可申请)
📣 系好安全带,准备迎接下个月的到来...
六月带来17个PDUFA决定:🔥 🔥
$Catalyst Pharmaceuticals (CPRX.US)$ : FIRDAPSE®(阿米替普啶)
$葛兰素史克 (GSK.US)$ : Arexvy
$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : Elafibranor
$再生元制药公司 (REGN.US)$ : Kevzara (sarilumab)
$施贵宝 (BMY.US)$ : Augtyro...
Rocket Pharmaceuticals Inc - 在Rp-L301治疗后36个月内对Pkd患者具有良好的耐受性安全概况
Abeona Therapeutics ( $Abeona Therapeutics (ABEO.US)$ )
Asset: Pz-cel (prademagene zamikeracel)
PDUFA Date: May 25, 2024
Indication: Recessive dystrophic epidermolysis bullosa (RDEB)
Technology: Autologous cell therapy, treatment uses gene transfer to deliver COL7A1 genes into an RDEB patient’s own skin cells then transplanting them back to the patient.
Rocket Pharmaceuticals ( $Rocket Pharmaceuticals (RCKT.US)$ ) ...
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