FDA accepts UCB’s sBLA for Bimzelx
April 5, 2024Medical Communications Bimzelx, FDA, Pharmacy, UCB, sBLA
UCB has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application …
FDA approves Basilea’s antibiotic Zevtera for three indications
April 4, 2024Medical Communications Basilea Pharmaceutica, FDA, Infections and infestations, Zevtera, antibiotic
Basilea Pharmaceutica has announced that the US Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection), …
Ironic Biotech announces $1m funding to develop iron deficiency and anaemia treatment
April 4, 2024Sales and Marketing Haematology, Ironic Biotech, anaemia, funding, iron deficiency
Swedish biotech startup Ironic Biotech has announced that it has successfully closed a pre-seed funding round of $1m, led by …
FDA approves Eko Health’s AI for heart failure detection
April 3, 2024Medical 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, 2024Research 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, 2024Research 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, 2024Business 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, 2024Business 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, 2024Business 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, 2024Business 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, 2024Medical 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, 2024Research 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, 2024Research 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, 2024Business 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, 2024Medical 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, 2024Medical 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, 2024Medical 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, 2024Medical 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 …
MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment
March 21, 2024Medical 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, 2024Research 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 …
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