Research and Development

Showing 15 posts of 9599 posts found.

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FDA approves BMS’s Reblozyl for treatment of anaemia in adults with lower-risk MDS

August 30, 2023 Research and Development FDA, Haematology, Reblozyl, anaemia, bristol myers squibb, myelodysplastic syndromes

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the …

EC approves Roche’s Evrysdi for babies under two months with SMA

August 30, 2023 Research and Development European Commission, Evrysdi, Musculo-skeletal disorder, Roche, spinal muscular atrophy

Roche has announced that the European Commission (EC) has approved the extension of Evrysdi’s marketing authorisation in the EU to …

FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab

August 29, 2023 Research and Development FDA, Faron, ODD, Oncology, leukemia

Faron Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its …
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Janssen submits sNDA to FDA for full approval of Balversa

August 29, 2023 Research and Development Balversa, FDA, Janssen, Oncology

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to …

Lynparza granted approval to treat prostate cancer in Japan

August 25, 2023 Research and Development Merck, Oncology, astra zeneca, prostate cancer

AstraZeneca and Merck (known as MSD outside the US and Canada) have received approval from the Japanese Ministry of Health, …

GSK confirms positive results from shingles trial in China

August 23, 2023 Research and Development GSK, Infections and infestations, clinical trials, shingles

GSK has announced positive results today from its first efficacy trial for Shingrix recombinant zoster vaccine (RZV) in China. These …

Eli Lilly shares topline results from LIBRETTO-531 trial for Retevmo

August 23, 2023 Research and Development Eli Lilly, Oncology, Retevmo, clinical trial, slpercatinib, thyroid cancer

Eli Lilly has announced topline results from the LIBRETTO-531 study assessing Retevmo (selpercatinib) as an initial treatment for patients with …

Merck announces phase 3 LITESPARK-005 trial met primary endpoint

August 22, 2023 Research and Development Merck, Oncology, Welireg, belzutifan, clinical trial, renal cell carcinoma

Merck (known as MSD outside of the US and Canada) has shared topline results from its phase 3 LITESPARK-005 trial, …

FDA approves Pfizer’s vaccine for the prevention of RSV in children

August 22, 2023 Research and Development FDA, Paediatrics, Pfizer, RSV

On Monday, Pfizer announced that the US Food and Drug Administration (FDA) has approved Abrysvo for the prevention of respiratory …

Recce Pharmaceuticals shares data from phase 1/2 trial for burn wound infection

August 21, 2023 Research and Development Recce Pharmaceuticals, Wound Healing, burn wounds, clinical trial, infection

Recce Pharmaceuticals has announced that it has completed its data analysis for its phase 1/2 clinical trial of Recce 327 …
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Hutchmed announces phase 3 trial met primary endpoint for primary immune thrombocytopenia treatment

August 21, 2023 Research and Development HUTCHMED, Haematology, clinical trial, sovleplenib, thrombocytopenia

Hutchmed has announced that its phase 3 trial ESLIM-01 trial assessing the use of sovleplenib has met its primary endpoint …

FDA approves first ever treatment for rare CHAPLE disease

August 21, 2023 Research and Development CHAPLE disease, FDA, Rare Diseases, rare disease

The US Food and Drug Administration (FDA) has approved Regeneron’s Veopoz (pozelimab), a new treatment for CHAPLE disease for both …

FDA approves IMIDEX’s AI-powered device VisiRad XR

August 18, 2023 Research and Development FDA, Radiology, pharma, radiology

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug Administration (FDA) for its artificial …

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 …
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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 …
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