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Showing 15 posts of 1340 posts found.

Sirnaomics advances isSCC candidate into late-stage clinical development

June 20, 2023
Research and Development FDA, Oncology, Sirnaomics, clinical trial, isSCC

Global RNA therapeutics biopharmaceutical company Sirnaomics has announced that it has advanced its Squamous Cell Carcinoma in situ (isSCC) candidate …

News

GSK announces extension of FDA’s review for momelotinib

June 20, 2023
Medical Communications FDA, GSK, Oncology, momelotinib, new drug application

GSK has announced that the US Food and Drug Administration (FDA) has extended its review period for the new drug …

News
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Nordic Bioscience receives FDA Letter of Support for biomarker in aggressive tumour fibrosis

June 16, 2023
Research and Development FDA, Nordic Bioscience, Oncology, Roche, tumour fibrosis

Danish biomarker company Nordic Bioscience has announced that the US Food and Drug Administration (FDA) has awarded it a Letter …

News
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FDA gives Eagle Pharmaceuticals Qualified Infectious Disease Product (QIDP) and Fast-Track Designation for SCABP drug

June 15, 2023
Research and Development Eagle Pharmaceuticals, FDA, FDA fast-track, Immunology, SCABP

US-based pharmaceutical company Eagle Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted its severe community-acquired …

News

Critical Path Institute receives FDA Biomarker LOS for DIPI biomarkers

June 14, 2023
Research and Development Critical Path Institute, Endocrinology, FDA, biomarkers, pancreatic injury

US-based Critical Path Institute (C-Path) has announced that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and …

News
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AstraZeneca’s breast cancer drug given Priority Review by FDA

June 13, 2023
Business Services AstraZeneca, FDA, Oncology, breast cancer

UK-based pharmaceutical company AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application …

News
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Innate Pharma announces drug researched with Sanofi receives FDA Fast Track Designation

June 8, 2023
Research and Development Cancer, FDA, Haematology, Innate Pharma, Sanofi, haematology

Innate Pharma has announced that the drug jointly researched between itself and Sanofi has received US Food and Drug Administration (FDA) …

News

FDA approves ANDA of 20mg generic Nitisinone capsules

June 1, 2023
Medical Communications Analog Pharma, Dipharma, FDA, Nitisinone, Rare Diseases

Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has approved their 20mg nitisinone capsules, …

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FDA approves Pfizer’s RSV vaccine for older adults

June 1, 2023
Research and Development FDA, Infections and infestations, Pfizer, RSV, Vaccine

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its respiratory syncytial virus …

News

Bristol Myers Squibb’s NDA accepted by FDA

May 31, 2023
Medical Communications FDA, NDA, NSCLC, Oncology, bristol myers squibb

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) has been accepted by the …

News

Pulse Medical receives FDA BDD for its μFR system

May 30, 2023
Medical Communications BDD, Cardiology, FDA, Pulse Medical

Shanghai, China-based Pulse Medical Technology has announced that its 4th generation μFR system has received Breakthrough Device Designation (BDD) from …

News

FDA approves first oral antiviral to treat adult patients with COVID-19

May 26, 2023
Medical Communications COVID-19, FDA, Infections and infestations, paxlovid

The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and …

News

ZOLL remedē System receives FDA approval for sleep apnoea treatment

May 25, 2023
Medical Communications Ear Nose & throat, FDA, ZOLL, sleep apnoea

ZOLL Medical Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for its …

News

Artivion receives FDA PMA approval of PerClot; transfers designation to Baxter

May 24, 2023
Medical Communications Artivion, Baxter International, Cardiology, FDA, PMA, PerClot

US cardiac and vascular surgery company Artivion has announced that the US Food and Drug Administration (FDA) has granted a …

News

FDA approves Innoviva’s Xacduro for intravenous use

May 24, 2023
Medical Communications FDA, Infections and infestations, Innoviva, pneumonia

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, has announced that the US Food and Drug Administration (FDA) has approved Xacduro …

News

Latest content

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

September 22, 2023

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan performs well in phase 3 trial

September 22, 2023

Novo Nordisk partners with UNICEF to prevent global childhood obesity

September 21, 2023

EC approves Menarini Group’s Orserdu for breast cancer treatment

September 21, 2023

Pharmanovia acquires CNS portfolio from Sanofi

September 20, 2023