News
The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.
Amneal Launches Third Biosimilar with FYLNETRA™ in the United States
Wednesday, May 17, 2023Amneal Pharmaceuticals Inc NYSE AMRX Amneal or the Company today announced the commercial launch of FYLNETRA pegfilgrastimpbbk a biosimilar referencing Neulastain a prefilled singledose syringe FYLNETRA is used to treat neutropenia low neutrophils wh...
Phio Pharmaceuticals Announces FDA Clearance to Initiate Clinical Trial of PH-762
Wednesday, May 17, 2023Phio Pharmaceuticals Corp Nasdaq PHIO a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells today announced that the US Food and Drug Administr...
Shorla Oncology & EVERSANA Announce Commercial Launch of Recent FDA-Approved Nelarabine Injection
Wednesday, May 17, 2023Shorla Oncology Shorla a USIreland pharmaceutical company and EVERSANA a leading provider of commercialization services to the life science industry today announced the commercial launch of the companys oncology drug Nelarabine Injection for the trea...
Kimera® Labs Receives FDA Phase I/IIa IND Approval For Its MSC Exosomes Human Study
Wednesday, May 17, 2023Kimera Labs Inc the first and leading worldwide MSC exosome research lab and producer is pleased to announce the FDA IND Investigational New Drug approval of its exosomes in a Phase IIIa clinical trial The trial will assess the safety and efficacy of...
PhenomeX Launches Beacon Select™ Optofluidic System with Opto® B Discovery Workflows
Tuesday, May 16, 2023PhenomeX Inc Nasdaq CELL the functional cell biology company today announced the launch of Beacon Select optofluidic system with Opto B Discovery workflows for antibody discovery
ImmPACT Bio Granted FDA Fast Track Designation for IMPT-314 in Patients with Relapsed or Refractory Aggressive B-cell Lymphoma
Tuesday, May 16, 2023ImmPACT Bio USA Inc ImmPACT Bio a clinicalstage company developing transformative logicgatebased chimeric antigen receptor CAR Tcell therapies for treating cancer and autoimmune diseases today announced the US Food and Drug Administration FDA has gra...
Innovent Receives NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma
Monday, May 15, 2023Innovent Biologics Inc Innovent HKEX a worldclass biopharmaceutical company that develops manufactures and commercializes highquality medicines for the treatment of oncology metabolic autoimmune ophthalmology and other major diseases announced that...
Oxford Biomedica launches the TetraVecta™ System
Monday, May 15, 2023Oxford UK May Oxford Biomedica plc LSEOXB Oxford Biomedica or the Company a quality and innovationled viral vector CDMO today announces the launch of its th generation lentiviral vector delivery system TetraVectaTM This stateoftheart technology de...
FDA approves first drug to treat symptoms of agitation associated with dementia due to Alzheimer's disease
Friday, May 12, 2023Today the US Food and Drug Administration FDA granted supplemental approval for Rexulti oral tablets brexpiprazole for the treatment of agitation associated with dementia due to Alzheimers disease This is the first FDAapproved treatment option for...
Invivoscribe Announces IVDR Approval of the LeukoStrat® CDx FLT3 Mutation Assay
Friday, May 12, 2023Today we are pleased to announce that Invivoscribes LeukoStrat CDx FLT Mutation Assay has been approved by BSI Netherlands and the EMA as a Class C CDx assay meeting the stringent new IVDR Regulation EU requirements Invivoscribe is one of the first...
