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Tag: drug application

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics, Inc. Announce Strategic Investor Relations Partnership with astr partners

WILMINGTON, Del., June 16, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE...

ArkBio’s New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

SHANGHAI, June 15, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted...

DRI Healthcare Trust Comments on FDA Delay for KalVista Pharmaceuticals’ Sebetralstat PDUFA Goal Date Due to FDA Resourcing Constraints

- FDA decision anticipated within four weeks - TORONTO, June 13, 2025 /CNW/ - DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) (the "Trust") today announced KalVista Pharmaceuticals...

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics, Inc. to Present at H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference

WILMINGTON, Del., June 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE...

Kelun-Biotech’s Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer

CHENGDU, China, June 11, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that the Company has received a clinical trial notice...

PESG Research Update: PolyPid SHIELD’s II Delivers Transformative Phase 3 Topline Results – Paradigm Shift in Surgical Infection Prevention

PESG issues a new briefing following PolyPid’s clinical success; Revolutionary 58% Reduction in Surgical Site Infections Positions PolyPid’s D-PLEX100 as Potential New Standard of Care in the Future
PESG issues a new briefing following PolyPid’s clinical success; Revolutionary 58% Reduction in Surgical Site Infections Positions PolyPid’s D-PLEX100 as Potential New Standard of Care in the Future

Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer

Target Action (PDUFA) Date set for October 7, 2025 Application based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and clinically...

Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT

SHANGHAI, June 10, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the...

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. – TVTX

NEW YORK, June 7, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Travere Therapeutics, Inc. ("Travere" or the "Company") (NASDAQ: TVTX). Such investors are...

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of UroGen Pharma Ltd. – URGN

NEW YORK, June 7, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of UroGen Pharma Ltd. ("UroGen" or the "Company") (NASDAQ: URGN). Such investors...

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biohaven Ltd. – BHVN

NEW YORK, June 7, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Biohaven Ltd.  ("Biohaven" or the "Company") (NYSE: BHVN).  Such...

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