Medical/Pharmaceuticals
Landmark Clinical Approval for YOLT-201 Obtained by the NMPA
SHANGHAI, March 4, 2024 /PRNewswire/ -- YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved the YOLT-2...
2024-03-04 20:00
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Caliway Announced Orphan Drug Designation Granted to CBL-514 for the Treatment of Dercum's Disease
- CBL-514 is the first and only drug to receive both Orphan Drug Designation and Fast Track designation for Dercum's disease treatment. NEW TAIPEI CITY, March 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orp...
2024-03-04 07:00
2943
NMPA Approves the NDA for CARsgen's BCMA CAR-T Therapy Zevorcabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
SHANGHAI, March 1, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that today the National Medical Products Administration ("NMPA") ofChi...
2024-03-01 21:50
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111 to Announce Fourth Quarter and Fiscal Year 2023 Unaudited Financial Results- Conference Call to Follow
SHANGHAI, March 1, 2024 /PRNewswire/ -- 111, Inc. (NASDAQ: YI) ("111" or the "Company"), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services inChina, today announced that it will report its unaudited financial results...
2024-03-01 17:00
3834
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.
BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of ...
2024-03-01 14:55
3907
SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Pancreatic Cancer
SEOUL, South Korea, Feb. 29, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced onFeb 27 that the US FDA had granted an orphan drug designation for pancreatic cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development, based on the pre-clinical dat...
2024-02-29 18:09
3591
Lunit Presents Seven Study Results at ECR 2024: Showcasing AI's Robust Performance in Diverse Clinical Settings
- Lunit to unveil four oral presentations and three poster presentations at ECR 2024, highlighting Lunit INSIGHT's expansive capability, ranging from adaptability in different use cases to the potential to replace a human reader in mammography double-reading settings SEOUL, South Korea, Feb. 28...
2024-02-28 22:03
2721
PharmAust announces positive Phase 1 MEND Study Top-Line Results in MND / ALS
Highlights: * Monepantel displays a superior safety, tolerability to the leading FDA approved drug Relyvrio® * Preliminary efficacy data shows a 58% reduction in the rate of disease progression for Cohort 2 (High Dose) using the FDA primary efficacy endpoint, ALSFRS-R * Confirmation that m...
2024-02-28 20:47
2528
Baird Medical Expands Presence in the United States
FRISCO, Texas, Feb. 28, 2024 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider inChina and the United States, today announced that it is accelerating its expansion inthe United States through ...
2024-02-28 18:00
2433
The promising results of a phase II clinical study for Akeso's Cadonilimab (PD-1/CTLA-4) combined standard treatment for first-line treatment of R/M cervical cancer has been published in Clinical Cancer Research
HONG KONG, Feb. 28, 2024 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody（cadonilimab）combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had be...
2024-02-28 17:27
2900
FDA Grants Fast Track Designation to 9MW2821
SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administ...
2024-02-27 22:00
2197
111 Announces Receipt of Withdrawal of Going Private Proposal
SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- 111, Inc. ("111" or the "Company") (NASDAQ: YI), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services inChina, today announced that it has received a notice dated Feburary 27, 20...
2024-02-27 21:58
3878
Nona Biosciences Enters into Collaboration Agreement with Boostimmune in Antibody-Drug Conjugate Development
CAMBRIDGE, Mass., Feb. 26, 2024 /PRNewswire/ -- Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited committed to cutting-edge technology innovations and providing a total solution from "Idea to IND" ("I to ITM"), announced today that it has entered into a collaboration agreement w...
2024-02-27 09:23
2844
BioCity Announces Enrollment Completion of the IgA Nephropathy (IgAN) Cohort in the Randomized, Placebo-controlled Phase II Clinical Trial of the ETA Receptor Antagonist SC0062
WUXI, China, Feb. 25, 2024 /PRNewswire/ -- BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor sel...
2024-02-26 22:38
2089
GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj.
* Immuncell-LC Inj. is an autologous Cytokine Induced Killer (CIK) cell therapy approved for Commercial use inSouth Korea as an adjuvant cell therapy for the treatment of Hepatocellular Carcinoma (HCC) after curative resection and has receivedFDA Orphan Drug Designations (ODDs) for liver, brain...
2024-02-26 21:30
2771
TransThera initiates IND-Enabling studies for TT-02332, a novel, highly potent and CNS-penetrating NLRP3 inhibitor
NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLR...
2024-02-26 21:00
2040
Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide
PISCATAWAY, N.J., Feb. 26, 2024 /PRNewswire/ -- Aucta Pharmaceuticals, Inc., a private specialty pharmaceutical company focused on niche generic and branded specialty products, today announced the commercial launch of MOTPOLY XR (lacosamide) extended-release capsules C-V (100, 150 and 200 mg). M...
2024-02-26 21:00
2175
J INTS BIO, Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI, accepted for presentation at the upcoming American Association for Cancer Research 2024 meeting in USA (AACR 2024)
SEOUL, South Korea, Feb. 26, 2024 /PRNewswire/ -- J INTS BIO announced on the 26th of month that the Phase 1/2 clinical study of its Novel Oral 4th Generation EGFR TKI "JIN-A02" for the treatment of NSCLC has been accepted for poster presentation at the upcoming American Association for Cancer Re...
2024-02-26 16:15
1859
Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024
WASHINGTON, Feb. 25, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, ...
2024-02-26 02:00
3253
China Medical University Hospital's Breakthrough: Leg Salvage Against Deadly Arterial Disease. Amputation and Death Rates Plunge from 30% to Below 3%
TAICHUNG, Feb. 24, 2024 /PRNewswire/ -- In winter, cardiovascular diseases are more prevalent, which significantly increase the likelihood of arterial blockage. In addition to increasing the possibility of accompanying myocardial infarction or stroke, seniors should be especially cautious about P...
2024-02-24 21:30
3447
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