Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA
August 18, 2023Medical Communications CHMP, EMA, Iveric Bio, MAA, Opthalmology
Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for avacincaptad pegol …
Dr Michael Lutz appointed as new chief executive officer of iotaSciences
August 18, 2023Business Services Dr Michael Lutz, Haematology, chief executive officer, iotasciences
The pharmaceutical discovery company iotaSciences has announced that it has appointed Dr Michael Lutz as its new chief executive officer. …
Foghorn Therapeutics appoints Alfonso Quintás-Cardama as new chief medical officer
August 18, 2023Business Services Alfonso Quintas-Cardama, Foghorn Therapeutics, Haematology, chief medical officer
The biotechnology company Foghorn Therapeutics has announced the addition of the new chief medical officer, Alfonso Quintás-Cardama, who will be …
Amicus Therapeutics’ Pompe disease treatment approved for use in UK
August 17, 2023Medical Communications Amicus Therapeutics, MHRA, NICE, Pompe disease, Rare Diseases
Amicus Therapeutics has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorisation …
FDA approved Ipsen’s Sohonos capsules for treatment of fibrodysplasia ossificans progressiva
August 17, 2023Medical Communications FDA, FOP, Musculo-skeletal disorder, Sohonos, ipsen
Ipsen has announced that the US Food and Drug Administration (FDA) has approved Sohonos (palovarotene) capsules as a retinoid indicated …
Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo
August 17, 2023Research and Development FDA, IND, Immunology, lupus nephritis, pharma
On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ Investigational New Drug (IND) application …
Sandoz shares positive results from MYLIGHT phase 3 study
August 16, 2023Research and Development Opthalmology, Sandoz, aflibercept, clinical trial, wet macular degeneration
Sandoz has announced positive results from the phase 3 MYLIGHT confirmatory efficacy and safety study for its biosimilar aflibercept, for …
Tempus receives FDA Breakthrough Device Designation for its companion diagnostic test
August 16, 2023Research and Development Diagnostics, FDA, Tempus, breakthrough device designation, diagnostic
Tempus has announced that the US Food and Drug Administration (FDA) has granted it Breakthrough Device Designation for its HLA-LOH …
FDA grants accelerated approval to Pfizer’s Elrexfio
August 15, 2023Medical Communications Elrexfio, FDA, Oncology, Pfizer, accelerated approval
Pfizer has that the US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment …
FDA grants orphan drug designation to Genprex’s Reqorsa
August 15, 2023Medical Communications FDA, ODD, Oncology, Reqorsa
Gene therapy company Genprex has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) …
NICE shares draft guidance for AI’s use in radiotherapy treatment planning
August 14, 2023Research and Development AI, Draft Guidance, NICE, Oncology, radiotherapy
The National Institute for Health and Care Excellence (NICE) has shared draft guidance surrounding nine artificial intelligence (AI) technologies which …
FDA approved Janssen’s Akeega for prostate cancer treatment
August 14, 2023Research and Development Akeega, FDA, J&J, Janssen, Oncology, prostate cancer
The Janssen Pharmaceutical companies of Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved …
Zumutor’s cancer drug trial cleared by FDA
August 14, 2023Research and Development Cancer, Oncology, clinical trial, pharmaceutical
On 11 August 2023, the biopharmaceutical company Zumutor Biologics announced that the trial of its ZM008 drug for cancer had …
FDA approves Talvey for the treatment of heavily pretreated multiple myeloma
August 11, 2023Medical Communications FDA, J&J, Janssen, Oncology, Talvey, multiple myeloma
The Janssen Pharmaceutical companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted …
Regeneron shares two-year PULSAR trial results for wAMD
August 11, 2023Medical Communications Opthalmology, PULSAR trial, Regeneron, wAMD
Regeneron Pharmaceuticals have announced positive, two-year, topline results from its PULSAR trial assessing aflibercept 8mg for the treatment of patients …
FDA accepts Astellas’ sNDA for Cresemba in children
August 11, 2023Research and Development Astella, FDA, Paediatrics, cresemba
The US Food and Drug Administration (FDA) announced it has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for Cresemba …
Sosei Heptares and Cancer Research UK announce first patient dosed in phase 1/2a trial
August 10, 2023Research and Development Cancer Research UK, Oncology, Sosei Heptares, clinical trial, immunology
Sosei Heptares and Cancer Research UK have announced that the first patient has been dosed in their phase 1/2a clinical …
Sunbird Bio and Glympse Bio merge for development of protein-based diagnostic technology
August 10, 2023Business Services Glympse Bio, Oncology, Sunbird Bio, merger, oncology
Sunbird Bio has announced that it has completed a merger with Glympse Bio, intending to accelerate the development of both …
Astellas set to open new life sciences facilities in Cambridge, Massachusetts
August 10, 2023Business Development Astellas Pharma, Pharmacy, pharmaceutical, science facility
On 9 August 2023, Astellas Pharma announced its plans to open what it has described as a “state-of-the-art life sciences …
EureKING planning creation of new biotech company through the acquisition of SCTbio
August 9, 2023Business Services, Research and Development Pharmacy
On 9 August 2023, eureKING announced it is set to acquire the pharmaceutical company SCTbio which specializes in cell and …
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