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Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362) Higher Dose 9 mg in Chinese Adults with Obesity
1/2/2024
Innovent Biologics, Inc. announces that the first participant has been successfully dosed in a Phase 3 clinical trial of higher dose 9 mg mazdutide, a glucagon-like peptide 1 receptor and glucagon receptor dual agonist, in Chinese adults with obesity.
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Coherus Announces U.S. Launch of LOQTORZI™
1/2/2024
Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States.
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Mabwell to attend 42nd JP Morgan Healthcare Conference and present at Biotech Showcase
1/2/2024
Mabwell, an innovative biopharmaceutical company with entire industry chain, announced that Dr. Hai Wu, R&D VP of Mabwell, will attend 42nd JP Morgan Healthcare Conference and present at Biotech Showcase in San Francisco, United States.
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Biodexa Appoints Ann Merchant to the Board of Directors
12/29/2023
Biodexa Pharmaceuticals PLC is pleased to announce the appointment of Ann Merchant to the Board of Directors of the Company as Non-executive Director with effect from 31 December 2023.
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Innovent and Xuanzhu Enter into Clinical Trial Collaboration Investigating Combination Therapy of Sintilimab (PD-1 inhibitor) and A Novel ADC Candidate for Advanced Solid Tumors in China
12/28/2023
Innovent Biologics, Inc. and Xuanzhu Biopharma, announce that they entered into a clinical trial collaboration and supply agreement for the combination therapies of sintilimab injection with KM-501, a novel HER-2 bispecific ADC, as potential treatment options for advanced solid tumors in China.
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Innovent and SanegeneBio Enter Strategic Collaboration to Develop siRNA Drug for the Treatment of Hypertension
12/27/2023
Innovent Biologics, Inc. and Sanegene Bio USA Inc. announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen for the treatment of hypertension.
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Amgen Provides Regulatory Update on Status of LUMAKRAS® (Sotorasib)
12/26/2023
Amgen announced that the U.S. Food and Drug Administration has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS®.
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Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
12/26/2023
Coherus BioSciences, Inc. announced that the U.S. Food and Drug Administration approved UDENYCA ONBODY™, the company's on-body injector presentation of UDENYCA®, a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
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It has been a topsy-turvy year marked by record bankruptcies, a sharp drop in funding, few IPOs, and a steady stream of layoffs and regulatory challenges offset by M&A deals and the hot weight loss and antibody-drug conjugate markets.
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Organon To Present at the 42nd Annual J.P. Morgan Healthcare Conference
12/21/2023
Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9th, 2024, at 1:30 p.m. PT.
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Amneal to Participate at the 42nd Annual J.P. Morgan Healthcare Conference
12/21/2023
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 42nd Annual J.P. Morgan Healthcare Conference on January 9-10, 2024.
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TruTag Technologies and Spinnaker Biosciences Partner on a New Targeted, Controlled Release Therapy for Age-Related Macular Degeneration
12/20/2023
TruTag Technologies, Inc. and Spinnaker Biosciences, Inc. today announced that they have entered into a strategic supply partnership for TruTag's advanced nano-porous silica (pSi) particles to support the commercialization of Spinnaker's new therapy for the treatment of age-related macular degeneration (AMD).
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New Drug Application of Mabwell's 8MW0511 for Injection Accepted by NMPA
12/19/2023
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National Medical Products Administration (NMPA).
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FDA Roundup: December 19, 2023
12/19/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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AnHeart Therapeutics and Innovent Announce China’s NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation
12/18/2023
AnHeart Therapeutics (“AnHeart”) and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review Designation for the New Drug Application (NDA) of taletrectinib.
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Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation
12/18/2023
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) and AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review Designation[1] for the New Drug Application (NDA) of taletrectinib.
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Innovent Announces Publication of Mazdutide (IBI362) Phase 2 Full Results in Chinese Patients with Overweight or Obesity in Nature Communications
12/18/2023
Innovent Biologics, Inc. announces that results of a Phase 2 clinical trial of mazdutide, a glucagon-like peptide-1 receptor and glucagon receptor dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications.
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Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines
12/18/2023
Organon becomes the sole distributor and promoter of Emgality ® (galcanezumab) and RAYVOW ™ (lasmiditan) in Europe, building on strong commercial expertise in central nervous system disorders.
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Amneal Announces Move to Nasdaq - December 15, 2023
12/15/2023
Amneal Pharmaceuticals, Inc. announced that it will transfer its stock exchange listing to the Nasdaq Stock Market from the New York Stock Exchange.
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CorMedix Inc. Announces Appointment of Chief Legal Officer
12/15/2023
CorMedix Inc. (Nasdaq: CRMD) today announced the appointment of Beth Zelnick Kaufman, Esq. as EVP, Chief Legal Officer, and Corporate Secretary, effective December 12, 2023.