Lee’s Pharmaceutical Secures NMPA Approval for Adasuve, Pioneering Loxapine Inhaler for Agitation
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured marketing approval from China’s National Medical Products...
Product approvals
AK Medical Holdings Receives NMPA Approval for Hip Surgery Navigation System iBot
AK Medical Holdings Ltd (HKG: 1789), a Chinese medical technology company, has announced that it...
Everest Medicines’ Nefecon for IgAN Receives NMPA Approval in China
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that its New Drug Application...
Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication...
Fujian Cosunter’s Oral COVID-19 Therapy Receives Conditional Approval in China
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its...
Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval...
Boehringer Ingelheim and Eli Lilly’s Jardiance Receives NMPA Approval for CKD Treatment
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced that their SGLT2 inhibitor, Jardiance...
Boehringer Ingelheim and Eli Lilly Secure NMPA Approval for Jardiance in Chronic Kidney Disease
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced the receipt of marketing approval...
RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete...
Sumitomo Pharma Receives Chinese Approval for Xenleta to Treat Pneumonia
Japan-based Sumitomo Pharma Co., Ltd (OTCMKTS: DNPUF) has secured market approval in China for Xenleta...
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...
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...