AllSci News
Ocugen's gene therapy gets FDA RMAT for geographic atrophy
Ocugen, Inc. (Nasdaq: OCGN), a Malvern, Pennsylvania-based biotechnology company, announced that the US FDA has granted Regenerative Medicine Advanced...
J&J's Rybrevant Faspro gains priority review for head and neck cancer after immunotherapy failure
Johnson & Johnson (NYSE: JNJ) announced that the US FDA has granted Priority Review to the supplemental Biologics License Application (sBLA) for amivantamab...
Astrin Bio and University of Minnesota report plasma proteomics classifier for early-stage breast cancer detection
Researchers at Saint Paul, Minnesota-based Astrin Biosciences, working with collaborators at the University of Minnesota Masonic Cancer Center, Mayo Clinic,...
Kaigene licenses Japan rights to FcRn inhibitor KG006 to Taisho in deal worth up to USD 378m
Rockville, Maryland-based Kaigene, Inc. has granted Taisho Pharmaceutical Co., Ltd. exclusive rights to develop, register, and commercialize KG006 (CT-P77)...
Apnimed raises USD 192m in IPO ahead of Q1 2027 sleep apnea drug decision
Cambridge, Massachusetts-based Apnimed, Inc. (Nasdaq: APMD), whose lead oral sleep apnea candidate carries an active FDA new drug application (NDA) and a Q1...
miRecule partners with EMS subsidiary to expand RNA delivery beyond the liver
Gaithersburg, Maryland-based miRecule, Inc. and Brazil-based Rio Biofarma Brasil Ltda. (RBBL), an EMS S.A. subsidiary, announced a research collaboration to...
EU approves Datroway as first TROP2 ADC with OS benefit in first-line metastatic TNBC
The European Commission has approved Datroway (datopotamab deruxtecan) as monotherapy for the 1st-line treatment of adult patients with unresectable or...
Karyopharm to file myelofibrosis sNDA after FDA backs SVR35 surrogate endpoint
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), headquartered in Newton, Massachusetts, announced plans to submit a supplemental New Drug Application (sNDA) to...
FDA grants Aspen RMAT designation for cell therapy in Parkinson's disease
San Diego-based Aspen Neuroscience, Inc. announced receipt of US FDA Regenerative Medicine Advanced Therapy (RMAT) designation for sasineprocel (ANPD001),...
Relation expands GSK collaboration to USD 110m with MORGAN foundation model for target discovery
UK-based Relation Therapeutics Limited and GSK have announced an expanded research collaboration focused on generating large-scale human cellular...
Sumitomo's enzomenib gets FDA orphan drug designation for ALL
Marlborough, Massachusetts-based Sumitomo Pharma America, Inc. (SMPA) has secured US FDA orphan drug designation for enzomenib (DSP-5336) in acute...
Pfizer's Litfulo succeeds in Phase III vitiligo trials, setting up rivalry with Rinvoq
Pfizer (NYSE: PFE) reported positive topline Phase III results for ritlecitinib (Litfulo) in nonsegmental vitiligo (NSV), positioning the drug to become the...
Candid's trispecific CND319 enters first-in-human testing under UCB
San Diego-based Candid Therapeutics has initiated a first-in-human Phase I clinical trial of CND319, a dual-targeting T-cell engager (TCE) designed to...
Kite-backed study identifies inherited genetic predictors of CAR-T toxicity and expansion
Researchers at Massachusetts General Hospital in Boston, working with colleagues at the Broad Institute of MIT and Harvard and Santa Monica,...
Inovio raises USD 20m ahead of make-or-break FDA decision on INO-3107
Plymouth Meeting, Pennsylvania-based Inovio Pharmaceuticals (Nasdaq: INO) announced the pricing of a USD 20 million underwritten public offering on July 29,...
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