Pharmaceuticals
Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery
TAIPEI, March 4, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-opera...
2024-03-05 06:55
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ACROBiosystems Launches New Initiative to Support Cell and Gene Manufacturers
NEWARK, Calif., March 4, 2024 /PRNewswire/ -- ACROBiosystems, one of the leading providers of innovative tools and solutions used from discovery to the clinic, has announced a new corporate initiative to supportex vivo cell manufacturing and manufacturers of innovative cell and gene therapies. I...
2024-03-04 22:00
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Henlius Forecasts Profit in 2023: Achieving first full year of profitability, and ushering in a new phase of high-quality development
SHANGHAI, March 4, 2024 /PRNewswire/ -- Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended31 December, 2023 (the "Reporting Period") and the information currently available to the Board,it...
2024-03-04 21:28
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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
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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
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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
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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
1620
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
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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
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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
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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
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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
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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
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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
1102
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
1101
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
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Oscotec/ADEL Initiates First-in-Human Dosing in Ph1 of Anti-MTBR Tau Antibody ADEL-Y01 In Alzheimer's Disease
PANGYO, South Korea, Feb. 23, 2024 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a novel disease-modifying immunothera...
2024-02-23 21:00
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Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors
- The first EpCAM targeted CAR-T product obtained US/CN IND approval. - Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001. SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell ...
2024-02-23 12:51
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