News and Trends 29 Mar 2023
Pharming immunodeficiency drug given FDA approval
Pharming Group N.V. has announced that the US Food and Drug Administration (FDA) has approved Joenja (leniolisib) for the treatment…
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Best in Biotech 9 Mar 2023
5 advancements in kidney disease research over the past year
Prevalent in millions of people across the globe, kidney diseases manifest through various symptoms like blood and excess protein in…
Interview 3 Mar 2023
Interview: how has the first gene therapy for hemophilia B transformed research?
Hemophilia B, a rare disease that affects more than 230,000 people worldwide is caused by the lack of or defective…
News and Trends 3 Mar 2023
Orphan drug designation for Laevoroc metabolic immune checkpoint inhibitor
Laevoroc Immunology, a privately-owned, Swiss oncology development company, has announced that the U.S. Food and Drug Administration (FDA) has granted…
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In Depth 3 Mar 2023
Let’s Take a Closer Look at 7 Autoimmune Diseases Biotechs are Fighting to Treat
While we mostly think of disease as being caused by bacteria or viruses, an illness can often occur when the…
News and Trends 24 Feb 2023
Sanofi hemophilia drug gets FDA approval
The U.S. Food and Drug Administration (FDA) has approved Sanofi's ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to…
News and Trends 23 Feb 2023
Depression trial gets green light
Beckley Psytech Ltd has received investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a…
News and Trends 21 Feb 2023
FDA approves alpha-mannosidosis drug
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), says the…
News and Trends 10 Feb 2023
FDA approves GSK drug for recurrent or advanced mismatch repair-deficient endometrial cancer
GSK plc says the US Food and Drug Administration (FDA) has given full approval for Jemperli (dostarlimab-gxly) for the treatment…
News and Trends 10 Feb 2023
Rocket Pharmaceuticals receives FDA RMAT designation for Danon disease gene therapy treatment
Rocket Pharmaceuticals, Inc says the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to…
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News and Trends 7 Feb 2023
Endogena Therapeutics retinitis pigmentosa treatment gets FDA fast track designation
The US Food and Drug Administration (FDA) has designated the investigation of Endogena Therapeutics’ EA-2353 for the treatment of retinitis…
News and Trends 3 Feb 2023
Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug
Genoscience Pharma has announced that its lead candidate, ezurpimtrostat, a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor, has been granted orphan drug…
News and Trends 31 Jan 2023
Stemline Therapeutics’ breast cancer treatment approved
The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and Drug Administration (FDA) has approved…
News and Trends 31 Jan 2023
Stargardt disease treatment gets FDA fast track
Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food…
News and Trends 31 Jan 2023
Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor
Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the…
News and Trends 27 Jan 2023
FDA clearance for ‘revolutionary’ approach to J-Pouch issue
ExeGi Pharma LLC, which develops live biotherapeutic drugs and probiotics, says the FDA has cleared its Investigational New Drug (IND)…
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News and Trends 11 Jan 2023
Renexxion goes to FDA with cystic fibrosis drug
Renexxion Ireland Limited has opened an investigational new drug (IND) application with the U.S Food and Drug Administration (FDA) for…
News and Trends 11 Jan 2023
AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma
Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra for the as-needed treatment or prevention…
News and Trends 9 Jan 2023
BD and CerTest Biotec receive emergency use authorization for mpox test
BD (Becton, Dickinson and Company), and CerTest Biotec have announced emergency use authorization (EUA) from the U.S. Food and Drug…
News and Trends 9 Jan 2023
Rani Therapeutics provides pipeline update
Rani Therapeutics Holdings, Inc. has completed a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA)…