Parc d’Innovation, Illkirch, France – Transgene (Euronext Paris: FR0005175080) announces that it recently met with the U.S. Food and Drug Administration (FDA) for an end of Phase II meeting when results of its TG4010 controlled phase IIb clinical trial in non-small-cell lung cancer (NSCLC) were reviewed. As per the minutes...
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SAN FRANCISCO, Calif. — Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. (“Biostar,” stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that its core pipeline product Utidelone has once again been...
NEEDHAM, Mass. — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to FORZINITY™ (elamipretide HCl) to improve muscle strength in...
Ingelheim am Rhein, Germany – Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating...
TOKYO, Japan –Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. VOYXACT...
VANCOUVER, BC – Bold Therapeutics, a clinical-stage biopharmaceutical company, is announcing that the U.S. Food & Drug Administration (FDA) has granted BOLD-100 an Orphan Drug Designation (ODD) in the treatment of gastric (stomach) cancer. BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR)...
Basel – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on...
SAN DIEGO, Calif. — Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota) for the treatment of Duchenne muscular dystrophy (DMD)...
WILMINGTON, Del. — Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for the treatment of patients with essential thrombocythemia (ET) harboring a Type 1 CALR mutation who are resistant or intolerant to...
THOUSAND OAKS, Calif. — Beren Therapeutics P.B.C.®, a Public Benefit Corporation and parent company of Mandos LLC®, today announced that Mandos received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational drug for infantile-onset Niemann-Pick disease type C (NPC). BTD is granted by the...