萬達生物製藥股票討論區

$萬達生物製藥(VNDA.US)$ PDUFA
$Intra-Cellular Therapies(ITCI.US)$ Phase 3
$施貴寶(BMY.US)$ PDUFA
$Alzamend Neuro(ALZN.US)$ Phase 2
$Alzamend Neuro(ALZN.US)$ Phase 2a

Last week’s PDUFAs:
$百濟神州(BGNE.US)$ : Approved 3/8 🎉
⇒ BRUKINSA + obinutuzumab
⇒ Follicular Lymphoma
⇒ sNDA
⇒ PDUFA date: Mar 2024
$施貴寶(BMY.US)$ : Approved 3/8 🎉
⇒ Opdivo ®  + Cisplatin & Gemcitabine
⇒ Urothelial carcinoma
⇒ sBLA
⇒ PDUFA: 04/05/24
$萬達生物製藥(VNDA.US)$ : CRL 3/4 🙁
⇒ HETLIOZ® 
⇒ insomnia
⇒ sNDA
⇒ PDUFA: 03/04/24
$Eyenovia(EYEN.US)$ : Approved 3/4 🎉
⇒ Clobetasol propionate ophthalmic susp. 0.05% (APP13007)
⇒ postop eye pa...

$萬達生物製藥(VNDA.US)$
⚠️ FDA issued CRL for sNDA for HETLIOZ® for treatment of insomnia on Mar 4th 🙁
🔎 VNDA is reviewing CRL and evaluating next steps…
🗓️ PDUFA date: 03/04/24

The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
$Eyenovia(EYEN.US)$$萬達生物製藥(VNDA.US)$$Mirum Pharmaceuticals(MIRM.US)$$Madrigal Pharmaceuticals(MDGL.US)$$傑龍(GERN.US)$$施貴寶(BMY.US)$$2seventy bio(TSVT.US)$$傳奇生物(LEGN.US)$$OptiNose(OPTN.US)$$Orchard Therapeutics(ORTX.US)$$默沙東(MRK.US)$$Akebia Therapeutics(AKBA.US)$$阿斯利康(AZN.US)$$Liquidia(LQDA.US)$$Esperion Therapeutics(ESPR.US)$$再生元製藥公司(REGN.US)$$百濟神州(BGNE.US)$

$萬達生物製藥(VNDA.US)$ WASHINGTON, Feb. 5, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclud...

$萬達生物製藥(VNDA.US)$ WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis.
Onychomycosis, or tinea unguium, is a fungal infection of the nail. Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the nail bed), and nail plate thicken...

$萬達生物製藥(VNDA.US)$ Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis
1 MINUTE AGO, 9:00 AM EST
VIA PR NEWSWIRE

$萬達生物製藥(VNDA.US)$ Vanda Pharmaceuticals Announced Court Granted Vanda's Motion For Summary Judgment On Its Claim Against The FDA

$萬達生物製藥(VNDA.US)$ Vanda Pharmaceuticals Says US Patent Office Issued Notice of Allowance for Multiple Sclerosis Therapy Application
MT Newswires· 3 mins ago

$萬達生物製藥(VNDA.US)$ Vanda: Seeking Compensation From U.S. for the Takings It Contends Occurred Through FDA's Improper Communication and Disclosure of Trade Secrets and Confidential Info to Certain Generic Drug Manufacturers >VNDA
Dow Jones· 4 mins ago