FDA approves Eko Health’s AI for heart failure detection

April 3, 2024
Medical Communications Cardiology, Eko Health, FDA, heart failure, low ejection fraction

Eko Health has announced that the US Food and Drug Administration (FDA) has approved its Low Ejection Fraction (Low EF) …

EnteroBiotix begins phase 2 trial of IBS treatment

April 3, 2024
Research and Development EnteroBiotix, Gastrointestinal tract, IBS, irritable bowel syndrome

EnteroBiotix has announced that it has dosed the first patient in its multi-centre, randomised, double-blind, placebo controlled clinical trial, which …

FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment

April 2, 2024
Research and Development AstraZeneca, Daiichi Sankyo, FDA, Oncology, bla, breast cancer

AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-Dxd) has been accepted in …

FDA approves Roche’s test for malaria in blood donors

April 2, 2024
Business Services FDA, Infections and infestations, blood donation, malaria

Roche has announced that the US Food and Drug Administration (FDA) has approved its cobas Malaria test for use on …

PMLiVE’s T40 – open for submissions!

March 28, 2024
Business Services PMLive, PMLive T40, Pharmacy, T40

Healthcare agencies can submit their entries free of charge with a deadline of 30 April The 2024 edition of PMLiVE’s …

Abenza announces investment in bioconjugation and ADC capabilities

March 28, 2024
Business Services ADC, Abenza, Pharmacy, bioconjugation, investment

Abenza has announced a major investment in bioconjugation and antibody drug conjugate (ADC) capabilities in response to an increasing industry …

Provectus Biopharmaceuticals announces license agreement with University of Miami

March 28, 2024
Business Services License Agreement, Opthalmology, Provectus Biopharmaceuticals, University of Miami

Provectus Biopharmaceuticals has announced that it has entered into an exclusive worldwide license agreement with the University of Miami, US …

FDA approves Merck’s Winrevair for PAH treatment

March 27, 2024
Medical Communications Cardiology, FDA, Merck, Winrevair, pulmonary arterial hypertension

Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) …

Heidelberg Pharma gains FDA ODD for ATAC candidate

March 27, 2024
Research and Development FDA, Oncology, heidelberg pharma, multiple myeloma

Heidelberg Pharma has announced that it has gained Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) …

Curve Therapeutics’ CSO publishes research on HIF inhibition for cancer treatment

March 26, 2024
Research and Development Cancer, Curve Therapeutics, HIF inhibition, Oncology, oncology

Curve Therapeutics has announced that its chief scientific officer, Professor Ali Tavassoli has published research in the Journal of the …

AbbVie to acquire Landos Biopharma for approximately $137.5m

March 26, 2024
Business Services AbbVie, Landos Biopharma, Pharmacy, acquisition

AbbVie and Landos Biopharma have announced that they have entered into a definitive agreement under which AbbVie will acquire Landos …

FDA approves AstraZeneca’s Ultomiris for NMOSD treatment

March 25, 2024
Medical Communications AstraZeneca, FDA, Neurology, Ultomiris, neuromyelitis optica spectrum disorder

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) as the first and only …

FDA approves J&J’s Opsynvi for PAH treatment

March 25, 2024
Medical Communications Cardiology, FDA, J&J, Johnson & Johnson, Opsynvi, pulmonary arterial hypertension

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil) …

FDA approves Idorsia’s Tryvio for treatment of high blood pressure

March 22, 2024
Medical Communications Cardiology, FDA, Tryvio, blood pressure, blood presure, hypertension

Idorsia has announced that the US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension …

CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment

March 22, 2024
Medical Communications CHMP, Diabetes, Novo Nordisk, diabetes

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended …

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MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment

March 21, 2024
Medical Communications Hyqvia, MHRA, Neurology, Takeda, chronic inflammatory demyelinating polyneuropathy

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a …

Sosei Heptares doses first patient in trial for inflammatory bowel disease treatment

March 21, 2024
Research and Development Gastrointestinal tract, Sosei Heptares, clinical trial, inflammatory bowel disease, phase 1 trial

Sosei Heptares has announced that it has dosed the first patient in its phase 1 trial assessing a novel EP4 …

Boehringer Ingelheim’s Spevigo gains additional approvals in US and China

March 20, 2024
Medical Communications Boehringer Ingelheim, Dermatology, FDA, Spevigo, psoriasis

Boehringer Ingelheim has announced that Spevigo (spesolimab-sbzo) has been approved by the US Food and Drug Administration (FDA) for the …

Lonza to acquire biologics site in Vacaville, US from Roche for $1.2bn

March 20, 2024
Manufacturing and Production Lonza, Pharmacy, Roche, biologics, facility, manufacturing

Lonza has announced that it has signed an agreement to acquire the Genentech large-scale biologics site based in Vacaville, California, …

J&J MedTech to work with NVIDIA for surgical AI

March 19, 2024
Research and Development Johnson & Johnson MedTech, NVIDIA, Pharmacy, surgery, surgical AI

Johnson & Johnson (J&J) MedTech has announced that it is working in collaboration with NVIDIA to accelerate and scale artificial …

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