Medical Communications

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AstraZeneca’s Tagrisso approved by FDA for lung cancer treatment

February 19, 2024 Medical Communications AstraZeneca, Oncology, Tagrisso, lung cancer

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Tagrisso for the treatment of adult patients …

Iovance’s Amtagvi gains FDA accelerated approval for melanoma treatment

February 19, 2024 Medical Communications Iovance, Oncology, accelerated approval, melanoma

Iovance Biotherapeutics has announced that the US Food and Drug Administration (FDA) has approved Amtagvi (lifileucel) suspension for intravenous infusion …

FDA approves Ipsen’s Onivyde for pancreatic adenocarcinoma treatment

February 14, 2024 Medical Communications FDA, Oncology, Onivyde, ipsen, pancreatic adenocarcinoma

Ipsen has announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for …

EC approves Vertex’s Casgevy for sickle cell disease treatment

February 13, 2024 Medical Communications Casgevy, European Commission, Haematology, Vertex pharmaceuticals, sickle cell disease

Vertex Pharmaceuticals has announced that the European Commission (EC) has granted conditional marketing authorisation to Casgevy (exagamglogene autotemcel), a CRISPR/Cas9 …

DelSiTech and Tolmar announce global license and development agreement

February 13, 2024 Medical Communications DelSiTech, Pharmacy, Tolmar, collaboration

DelSiTech and Tolmar International have announced that they have entered into a global license and development agreement, following a previous …

J&J’s nipocalimab gains breakthrough therapy designation from FDA for HDFN treatment

February 12, 2024 Medical Communications Breakthrough Therapy Designation, FDA, HDFN, J&J, Reproductive health

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) …

GSK gains FDA Fast Track designation for chronic hepatitis B treatment

February 12, 2024 Medical Communications FDA, GSK, Hepatology, fast track designation, hepatitis B

GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational …

Fresenius Medical Care gains FDA 501(k) clearance for haemodialysis system

February 9, 2024 Medical Communications 501(k), FDA, Fresenius Medical Care, Nephrology, dialysis

Fresenius Medical Care has announced that it has received US Food and Drug Administration (FDA) 501(k) clearance for its 5008X …

Regeneron’s linvoseltamab gains EMA filing acceptance for R/R MM treatment

February 5, 2024 Medical Communications EMA, Oncology, Regeneron, linvoseltamab, multiple myeloma

Regeneron Pharmaceuticals has announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorisation Application (MAA) for …

NICE recommends SC treatment of AbbVie’s Tepkinly for patients with DLBCL

February 1, 2024 Medical Communications AbbVie, DLBCL, NICE, Oncology, lymphoma

AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended Tepkinly (epcoritamab) as a treatment …
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FDA grants ODD to Revolo Biotherapeutics’ eosinophilic esophagitis treatment

February 1, 2024 Medical Communications FDA, ODD, Pharmacy, Revolo Biotherapeutics, eosinophilic esophagitis

Revolo Biotherapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, …

MHRA approves GSK’s Omjjara in Great Britain for splenomegaly treatment

January 31, 2024 Medical Communications GSK, MHRA, Omjjara, Oncology, myelofibrosis, splenomegaly

GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Omjjara (momelotinib) in …

EMA to review GSK’s Arexvy for RSV prevention in adults aged 50-59

January 29, 2024 Medical Communications Arexvy, EMA, Infections and infestations, RSV

GSK has announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of …

MHRA approves Mounjaro for diabetes and weight management

January 26, 2024 Medical Communications Diabetes, MHRA, Mounjaro, weight management

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it has approved a four-dose version of the diabetes …

Haleon recalls cough syrups due to microbial contamination

January 25, 2024 Medical Communications Haleon, Pharmacy, cough syrup, microbial contamination

The US Food and Drug Administration (FDA) has shared an announcement from Haleon detailing the voluntary recall of eight lots …
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