BioPharma Drug Approval
Merz Therapeutics Receives TGA Approval for XEOMIN® in Australia
This marks a significant milestone as XEOMIN® is the first approved neurotoxin for the treatment of this condition in the Australian market. Addit...
November 23, 2023 | News
Innovent and AnHeart's Taletrectinib NDA Accepted by China's NMPA
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...
November 23, 2023 | News
Ark Biopharma's AK0610 Receives NMPA IND Approval for RSV Neutralizing Antibody
It is anticipated to protect infants throughout an entire RSV season. ArkBio licensed the drug's intellectual properties from the Institute of Microb...
November 23, 2023 | News
Senhwa Biosciences Granted FDA IND for Phase II Study of Silmitasertib in Viral Community-Acquired Pneumonia (CAP)
The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether ...
November 22, 2023 | News
IASO Bio Sets Up Global CAR-T Center in China for Global MM Patients
On June 30, 2023, the China National Medical Products Administration (NMPA) approved the marketing of Equecabtagene Autoleucel Injection (brand name: FUCAS...
November 22, 2023 | News
KN026 was Granted Breakthrough Therapy Designation by CDE
Gastric cancer is one of the most common gastrointestinal malignancies in the world, and the number of new cases and deaths of gastric cancer in China...
November 08, 2023 | News
Everest Medicines Receives Approval in Macau for Nefecon® in Primary IgA Nephropathy
Everest Medicines (HKEX 1952.HK, "Everest," or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercializ...
October 30, 2023 | News
Life Molecular Imaging and Sinotau Gain Regulatory Approval for Neuraceq® in China
Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-...
October 25, 2023 | News
Australia's Certa Therapeutics: FT011 Granted US FDA Orphan Drug Status for Systemic Sclerosis
Orphan Drug Designation is granted by the FDA to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 pe...
October 24, 2023 | News
FDA Approves PENBRAYA™: First Vaccine for 5 Common Meningococcal Serogroups in Teens
PENBRAYA™ provides the broadest serogroup coverage (meningococcal groups A, B, C, W and Y) of any meningococcal vaccine available in the U.S. ...
October 23, 2023 | News
FDA Approves Pfizer's VELSIPITY™ for Severe UC in Adults
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selectiv...
October 16, 2023 | News
CANbridge's CAN108 (LIVMARLI®) Receives Approval in Taiwan for ALGS-Related Pruritus
CANbridge Pharmaceuticals Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development ...
October 09, 2023 | News
FDA Grants Orphan Drug Status to GC Biopharma's Thrombocytopenic Purpura Drug in South Korea
When designated as an orphan drug, there are incentives such as tax credits for clinical development costs and exemptions from PDUFA user fees Initial Pedi...
October 06, 2023 | News
FDA Clears Transcenta for Global Phase III Trial of Osemitamab in Gastric Cancer
Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, resear...
October 04, 2023 | News
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