BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
The US Food and Drug Administration (FDA) has postponed the target action date for Bristol...
Product approvals
BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for...
Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical...
Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Beijing Avistone Pharmaceuticals...
Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval...
Yifan Pharmaceutical’s Subsidiary Receives FDA Approval for Ryzneuta (F-627)
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd.,...
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory...
BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY)...
Easton Pharmaceutical Receives FDA Approval for Generic Nalmefene
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA)...
Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the...
Sino Medical Sciences Technology’s HT Supreme Stent Gains Brazilian Market Approval
Sino Medical Sciences Technology Inc., (SHA: 688108) a leading China-based medical device company, has announced...
EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA)...
Sansure Biotech Secures CE IVDR Certifications for Chemiluminescence Analyzers in the EU
China-based molecular diagnostics specialist, Sansure Biotech Inc., (SHA: 688289), has announced that it has received...
Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has...
AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
The National Medical Products Administration (NMPA) of China has indicated on its website that it...
China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT...
Eli Lilly’s Zepbound Approved by FDA for Chronic Weight Management in Adults
Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration...
Sino Medical Sciences Technology Secures EU MDR Approval for HT Supreme Drug-Eluting Stent System
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received Medical...
Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from...
Lifetech Scientific Corporation Receives NMPA Approval for Peripheral Thrombus Suction Catheter
Lifetech Scientific Corporation (HKG: 1302), a China-based medical device company, has announced that it has...