Simcere and Connect Biopharma’s Rademikibart NDA Accepted by China’s NMPA for Atopic Dermatitis
The New Drug Application (NDA) for rademikibart, an anti-inflammatory monoclonal antibody (mAb) co-developed by China’s...
Market approval filings
Guangdong Taienkang Submits Marketing Application for Generic Vuity to China’s NMPA
China-based Guangdong Taienkang Pharmaceutical Co., Ltd. (SHE: 301263) announced the submission of a marketing approval...
J&J Submits sNDA to FDA for Caplyta to Prevent Schizophrenia Relapse
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced the submission of a supplemental New...
RemeGen Submits New Indication Application for Disitamab Vedotin in Urothelial Carcinoma
RemeGen Ltd (HKG: 9995) announced that the National Medical Products Administration (NMPA) in China has...
Jiangsu Vcare PharmaTech’s VC004 NDA Accepted for Review by China’s NMPA
China-based Jiangsu Vcare PharmaTech Co., Ltd announced that its New Drug Application (NDA) for VC004...
Allergan Aesthetics’ SKINVIVE by JUVÉDERM Accepted for FDA Review to Reduce Neck Lines
Allergan Aesthetics, an AbbVie (NYSE: ABBV) company, announced that the supplemental premarket approval (sPMA) application...
CARsgen’s Satri-cel NDA Accepted by China’s NMPA for Gastric Adenocarcinoma
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the National Medical Products Administration (NMPA)...
GSK’s Linerixibat Accepted for EMA Review for Cholestatic Pruritus in PBC
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted the...
Sanofi’s Sarclisa Recommended for EU Approval in Newly Diagnosed Multiple Myeloma
France major Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Johnson & Johnson Submits sBLA to Expand Stelara Use for Pediatric Crohn’s Disease
US giant Johnson & Johnson (J&J, NYSE: JNJ) this week submitted a supplemental Biologics License...
Bayer Files NDA for Gadoquatrane, Aiming to Offer Lowest-Dose GBCA in the U.S.
Germany-based Bayer AG (ETR: BAYN) announced that it has made a New Drug Application (NDA)...
CDE Accepts NDA for Ark Bio’s Azstarys, a Priority-Reviewed ADHD Treatment
China’s Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for...
Zhaoke Ophthalmology’s TAB014 Receives BLA Review for wAMD Treatment
China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its Biologic License Application (BLA) for TAB014,...
Merck’s Pimicotinib NDA Accepted for Review by China’s CDE
German pharmaceutical major Merck KGaA (ETR: MRK) announced that the New Drug Application (NDA) for...
NMPA Accepts NDA for Innovent and HutchMed’s Tyvyt and Elunate Combination
Chinese companies Innovent Biologics, Inc. (HKG: 1801) and HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013)...
Huadong Medicine Files for NMPA Approval of Ranibizumab Biosimilar
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market approval filing for a...
GSK’s Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for...
Bayer Files for Approval of Gadoquatrane MRI Contrast Agent in Japan
German pharmaceutical giant Bayer AG (ETR: BAYN) this week filed a marketing application with Japan’s...
Lupeng Pharma’s Rocbrutinib Near Approval for Mantle Cell Lymphoma
Guangzhou Lupeng Pharmaceutical Co., Ltd’s rocbrutinib is currently under New Drug Application (NDA) review at...
JW Therapeutics’ Carteyva Receives Fourth sBLA for r/r LBCL
JW Therapeutics (HKG: 2126), a clinical-stage cell therapy company co-founded in 2016 by Juno Therapeutics...