FDA Archives

News and Trends 4 Oct 2022

FDA gives $1.3M grant to Biologics & Biosimilars Collective Intelligence Consortium

The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review. The study, “Improving the Efficiency of […]

October 4, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 3 Oct 2022

FDA clears Kira Pharmaceuticals’ phase 2 trial for SLE-TMA treatment

Kira Pharmaceuticals says the US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KP104, a first-in-class bifunctional biologic that selectively and synergistically targets the alternative and terminal complement pathways. A phase 2 trial will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with […]

October 3, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 3 Oct 2022

Poxel granted orphan drug designation for kidney disease treatment

French biopharma company Poxel SA says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator – and is also a phase 2 ready ADPKD asset, subject […]

October 3, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 29 Sep 2022

Treatment for adults with chronic skin condition approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases […]

September 29, 2022 - 4 minutesmins - By Liza Laws

News and Trends 27 Sep 2022

Protocol for treatment of neurotrophic keratopathy submitted to FDA by ReGenTree

Protocol for a second phase 3 clinical trial for a treatment for neurotrophic keratopathy (NK) – a degenerative disease of the corneal epithelium resulting from impaired corneal innervation, has been submitted. RegeneRx Biopharmaceuticals reported that its U.S. joint venture partner and licensee, HLB Therapeutics, together called ReGenTree, made the submission to the U.S. Food and […]

September 27, 2022 - 3 minutesmins - By Liza Laws

News and Trends 26 Sep 2022

Acticor Biotech enrolls first U.S. patient in study for people with acute ischemic stroke

The first U.S. patient was enrolled in a study evaluating glenzocimab in those with acute ischemic stroke. Acticor Biotech, a clinical stage biotech company, made the announcement today (September 26). The patient was enrolled at the CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by neurologist, Ruchir Shah. Significant potential He said: “I am very […]

September 26, 2022 - 3 minutesmins - By Liza Laws

News and Trends 26 Sep 2022

Commercial launch of monkeypox PCR test for research use in laboratories worldwide

A newly developed molecular polymerase chain reaction (PCR) test for monkeypox is now commercially available globally for research use only applications. Becton, Dickinson and Company (BD) and CerTest Biotec made the announcement today (September 26) that the test can be used in laboratories. The teams leveraged the BD MAX System open architecture reagent suite to develop […]

September 26, 2022 - 3 minutesmins - By Liza Laws

News and Trends 23 Sep 2022

Knockback for drug to treat patients with relapsed or refractory multiple myeloma

A Swedish biotech company says it believes its treatment could be the ‘canary in the coalmine’ despite a knockback. The Oncologic Drugs Advisory Committee (ODAC) has said it does not consider the treatment for patients with relapsed or refractory multiple myeloma (RRMM) favorable in a benefit-risk profile. Oncopeptides AB has been trialing Pepaxto in the […]

September 23, 2022 - 3 minutesmins - By Liza Laws

News and Trends 22 Sep 2022

New phase 1 biomarker results reported by Glyscend Therapeutics for diabetes drug

A U.S.-based biotech yesterday (September 21) reported additional biomarker results for a treatment of type 2 diabetes (T2D) from a phase 1 study. Glyscend Therapeutics, has been looking at orally administered drug GLY-200, which is a gut-restricted therapeutic. The company also received clearance from the U.S. Food and Drug Administration (FDA) on an Investigational New […]

September 22, 2022 - 4 minutesmins - By Liza Laws

News and Trends 21 Sep 2022

FDA clears Cellenkos ALS drug for trial

Cellenkos, Inc., a clinical stage biotech company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a phase 1 safety study followed by a phase 1b randomized, double blind, placebo control trial of CK0803, neurotrophic allogeneic Treg cells, in patients with amyotrophic lateral sclerosis […]

September 21, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 20 Sep 2022

Biopharma company Faron announces escalation data cancer treatment study

A clinical stage biopharma company has announced further dose escalation data from its phase 1/2 study looking at the safety and efficacy of a monotherapy in ten different hard-to-treat cancers. Latest progress from Faron Pharma’s MATINS (Macrophage Antibody To INhibit immune Suppression) study was focused on higher dose levels and frequencies to finalize the dose […]

September 20, 2022 - 4 minutesmins - By Liza Laws

News and Trends 19 Sep 2022

FDA approves Heron Therapeutics’ post-op nausea and vomiting drug

Heron Therapeutics, Inc. says the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults. Heron Therapeutics’ APONVIE is the first and only IV formulation of aprepitant for PONV prevention. Administered via a single 30-second IV injection, APONVIE reaches […]

September 19, 2022 - 3 minutesmins - By Jim Cornall

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FDA

FDA gives $1.3M grant to Biologics & Biosimilars Collective Intelligence Consortium

FDA clears Kira Pharmaceuticals’ phase 2 trial for SLE-TMA treatment

Poxel granted orphan drug designation for kidney disease treatment

Treatment for adults with chronic skin condition approved by FDA

Protocol for treatment of neurotrophic keratopathy submitted to FDA by ReGenTree

Acticor Biotech enrolls first U.S. patient in study for people with acute ischemic stroke

Commercial launch of monkeypox PCR test for research use in laboratories worldwide

Knockback for drug to treat patients with relapsed or refractory multiple myeloma

New phase 1 biomarker results reported by Glyscend Therapeutics for diabetes drug

FDA clears Cellenkos ALS drug for trial

Biopharma company Faron announces escalation data cancer treatment study

FDA approves Heron Therapeutics’ post-op nausea and vomiting drug

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10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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