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Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA

August 18, 2023
Medical 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 …

News

Dr Michael Lutz appointed as new chief executive officer of iotaSciences

August 18, 2023
Business 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. …

Appointment

Foghorn Therapeutics appoints Alfonso Quintás-Cardama as new chief medical officer

August 18, 2023
Business 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 …

Appointment

Amicus Therapeutics’ Pompe disease treatment approved for use in UK

August 17, 2023
Medical 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 …

News

FDA approved Ipsen’s Sohonos capsules for treatment of fibrodysplasia ossificans progressiva

August 17, 2023
Medical 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 …

News

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

August 17, 2023
Research 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 …

News
eye1

Sandoz shares positive results from MYLIGHT phase 3 study

August 16, 2023
Research 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 …

News
testalize-me-0je8ynv4mis-unsplash

Tempus receives FDA Breakthrough Device Designation for its companion diagnostic test

August 16, 2023
Research 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 …

News

FDA grants accelerated approval to Pfizer’s Elrexfio

August 15, 2023
Medical 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 …

News
lungs

FDA grants orphan drug designation to Genprex’s Reqorsa

August 15, 2023
Medical 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) …

News

NICE shares draft guidance for AI’s use in radiotherapy treatment planning

August 14, 2023
Research 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 …

News

FDA approved Janssen’s Akeega for prostate cancer treatment

August 14, 2023
Research 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 …

News

Zumutor’s cancer drug trial cleared by FDA

August 14, 2023
Research 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 …

News
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FDA approves Talvey for the treatment of heavily pretreated multiple myeloma

August 11, 2023
Medical 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 …

News
eye_2

Regeneron shares two-year PULSAR trial results for wAMD

August 11, 2023
Medical 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 …

News

FDA accepts Astellas’ sNDA for Cresemba in children

August 11, 2023
Research 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 …

News
towfiqu-barbhuiya-ssz6x-gao0c-unsplash

Sosei Heptares and Cancer Research UK announce first patient dosed in phase 1/2a trial

August 10, 2023
Research 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 …

News

Sunbird Bio and Glympse Bio merge for development of protein-based diagnostic technology

August 10, 2023
Business 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 …

News

Astellas set to open new life sciences facilities in Cambridge, Massachusetts

August 10, 2023
Business 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 …

News

EureKING planning creation of new biotech company through the acquisition of SCTbio

August 9, 2023
Business 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 …

News
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