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Medical Communications

Showing 15 posts of 6274 posts found.

AstraZeneca’s Voydeya recommended for approval in EU by CHMP

February 29, 2024 Medical Communications AstraZeneca, CHMP, EMA, Haematology, Voydeya

AstraZeneca has announced that Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) by the Committee …
News

Spero Therapeutics’ bacterial infection treatment gains FDA IND clearance

February 29, 2024 Medical Communications FDA, Infections and infestations, Spero Therapeutics, bacterial infections, investigational new drug

Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug …
News

FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review

February 22, 2024 Medical Communications FDA, Oncology, Regeneron, bla, priority review

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for …
News

Pfizer’s Velsipity approved by EC for ulcerative colitis treatment

February 20, 2024 Medical Communications European Commission, Gastrointestinal tract, Pfizer, Velsipity, ulcerative colitis

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) in the European Union (EU). …
News

argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment

February 20, 2024 Medical Communications CIDP, FDA, Neurology, Vyvgart Hytrulo, argenx, sBLA

argenx has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for …
News

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 …
News

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 …
News

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 …
News

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 …
News

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 …
News

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) …
News

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 …
News

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 …
News

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 …
News

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 …
News

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