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Sanofi’s mRNA Chlamydia Vaccine Gains FDA Fast Track Designation
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French pharmaceutical giant Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate targeting the prevention of chlamydia infection. This designation represents a significant step forward in the development of the vaccine, which is designed to…
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Sanofi’s Tolebrutinib Accepted for FDA Review in Non-Relapsing Secondary Progressive Multiple Sclerosis
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that a market filing for its tolebrutinib as a treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS) has been accepted for review by the US FDA. The agency is expected to make its decision by September 28, 2025. A regulatory submission is also under…
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Coherent Biopharma’s CBP-1019 Granted FDA Fast Track Status for Endometrial Cancer
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Coherent Biopharma Ltd, a Suzhou-based specialist in bispecific-ligand drug conjugates (Bi-XDC), announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to its lead candidate, CBP-1019, for the treatment of recurrent endometrial cancer in patients who have received prior platinum-based chemotherapy. FDA Designation and Drug ProfileThe…
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Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for ipilimumab, an anti-CTLA-4 monoclonal antibody (mAb), and granted it Priority Review designation. The application covers the drug’s use in combination with sintilimab as…
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Boehringer Ingelheim’s Zongertinib NDA Accepted by FDA for HER2-Mutated NSCLC
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Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zongertinib (BI 1810631). The drug is indicated for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have received prior systemic therapy. The…
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Sanofi’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP) and granted it priority review status. The FDA is expected to make its decision by June…
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Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), has been accepted by the US Food and Drug Administration (FDA) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date…
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Hansoh Pharma’s Uplizna Receives Priority Review for IgG4-RD Treatment
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that the National Medical Products Administration (NMPA) has granted priority review status to a new indication approval filing for its Uplizna (inebilizumab), a CD19 monoclonal antibody (mAb) co-developed with US-based Viela Bio Inc. The Chinese firm is seeking approval for the drug…
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CanSino Biologics’ DTcP Vaccine for Infants Gains Priority Review in China
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China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) announced that the New Drug Application (NDA) for its DTcP vaccine for infants and young children (under 2 years old), which was accepted for review by the National Medical Products Administration (NMPA) in December of last year, is now under priority review.…
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Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
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German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to its investigational drug nerandomilast. The drug is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and debilitating lung disease…
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FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted priority review status to the Biologics License Application (BLA) for its portfolio drug nipocalimab. This priority status is based on results from the Phase III Vivacity-MG3 study and is awarded for the product’s potential use…
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Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) for sunvozertinib has been accepted for review by the US FDA with priority review status. The EGFR inhibitor is targeting approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal…
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Huahui Health’s HH-003 Gains Priority Review Status for Chronic Hepatitis D Treatment
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has indicated that Huahui Health’s HH-003 is on track to obtain priority review status as a “drug eligible for conditional approval.” This designation is specifically for the treatment of chronic hepatitis D virus (HDV) infection. Drug Mechanism…
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CDE Indicates Priority Review for Boehringer Ingelheim’s Zongertinib and Peers
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…
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GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
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The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China. Blenrep: An Antibody-Drug Conjugate for Multiple MyelomaBlenrep is an innovative antibody drug conjugate (ADC) that…
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Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
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The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
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Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
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The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
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Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) is on the brink of a breakthrough in cancer treatment, with its drug SHR2554 receiving priority review status from China’s Center for Drug Evaluation (CDE). This enhancer of zeste homolog 2 (EZH2) inhibitor is set to revolutionize the treatment of patients with recurrent…
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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
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BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical Co., Ltd and Chengdu Institute of Biological Products Co., Ltd., part of Sinopharm, are on the path to priority review for their respective medical innovations. Ruidio’s Technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide…
