Boehringer Ingelheim & Sino Biopharma Secure Conditional Approval for Zongertinib in China
In a joint announcement, Boehringer Ingelheim (BI) and Sino Biopharmaceutical Limited (HKG: 1177) confirmed that the...
Conditional approvals
Huadong Medicine Seeks Regular Approval for Elahere in Ovarian Cancer Treatment
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to...
Amgen’s Imdylltra Gains Conditional Approval in UK for Extensive-Stage Small Cell Lung Cancer
US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and...
Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated...
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...
Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for...
NMPA Revises Drug Conditional Approval Procedures: Streamlined Processes and Requirements
The National Medical Products Administration (NMPA) has released the “Drug Conditional Approval Filing Review and...
European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ)...
Chipscreen Pharmaceutical’s Epidaza Granted Priority Status for DLBCL Treatment in China
The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd’s...
CDE Indicates Priority Review for Overland ADCT’s Zynlonta and BeiGene’s Brukinsa
The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY)...
Roche’s Rozlytrek on Track for Priority Review for Pediatric NTRK Fusion Tumor Treatment
The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib)...
Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN)...
TYK Medicines’ TY-9591 Gains CDE Green Light for Pivotal Phase II Study in NSCLC with Brain Metastases
Shanghai-based TYK Medicines has announced that it has received the green light from the Center...
Nanjing-Based Frontier Biotechnologies Secures Full Approval for Albuvirtide in China
Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary approval filing for albuvirtide, China’s first...
Merck’s Lagevrio Receives Emergency Conditional Approval from China’s NMPA
US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced receiving emergency conditional approval...