J&J’s SC Amivantamab Faces Complete Response Letter from FDA for NSCLC Treatment
Johnson & Johnson (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed...
Company
Grand Pharmaceutical’s GPN01768 Accepted for Review by NMPA for Demodex Blepharitis Treatment
Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration...
Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has...
Abbisko Therapeutics Receives NMPA Approval for Irpagratinib Regulatory Study
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval...
Vocabria Receives Positive CHMP Opinion for HIV Treatment in Adolescents
GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by...
GSK’s Jemperli Receives Positive CHMP Opinion for Endometrial Cancer Indication Extension
The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European...
GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation...
CanSino Biologics’ DTcP Vaccine for Infants and Young Children Accepted by NMPA for Review
China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products...
MicroPort NeuroTech Leads Investment Fund to Advance Brain Science Industry
China-based MicroPort NeuroTech Limited (HKG: 2172) has announced its commitment to invest RMB 200 million...
Candid Therapeutics Expands TCE Portfolio with Strategic Partnerships in Autoimmune Disease Treatment
US-based Candid Therapeutics Inc. is fulfilling its ambition to become a leader in advancing T-cell...
EMA Grants PRIME Designation to Hansoh Pharmaceutical’s HS-20093 in Collaboration with GSK
The European Medicines Agency (EMA) has conferred Priority Medicines (PRIME) designation to HS-20093 (GSK5764227), a...
Bio-Thera Solutions Expands License Deal with SteinCares for Latin American Market
China-based Bio-Thera Solutions (SHA: 688177) has announced the addition of a third biosimilar to its...
European CHMP Supports Conditional Approval of MSD’s Welireg for VHL Disease and RCC
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee...
EMA’s CHMP Recommends Approval of Bayer’s Acoramidis for ATTR-CM Treatment
Bayer’s (ETR: BAYN) acoramidis has received a positive recommendation from the Committee for Medicinal Products...
Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted...
Roche’s cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry
Global healthcare company Roche (SWX: ROG) has announced that its state-of-the-art cobas 6800/8800 Systems 2.0...
ARS Pharmaceuticals’ Neffy Receives Market Filings in Asia-Pacific Region
US-based ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has announced that market filings for its intranasal epinephrine...
Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it...
Quantum Hi-Tech (ChemPartner) Plans to Raise Over RMB 930 Million in Private Placement
Quantum Hi-Tech (China) Biotechnology Co., Ltd, known as ChemPartner (SHE: 300149), is poised to raise...
AbbVie Acquires Roche’s Nimble Therapeutics to Boost Immunology Pipeline
US pharmaceutical company AbbVie (NYSE: ABBV) has reached an agreement to acquire Swiss pharmaceutical giant...