Category - Developments

Developments

FDA grants Fast Track Designation to Cumberland’s ifetroban DMD program

Cumberland Pharmaceuticals (NASDAQ: CPIX) has received Fast Track Designation from the FDA for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. The FDA has...

February 4, 2026

Developments

FDA clears Nanox’s TAP2D image enhancement technology

Nanox (NASDAQ: NNOX) has announced receiving FDA 510(k) clearance for TAP2D, a new cloud-enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems. According to Nanox, the FDA...

February 3, 2026

Developments

USPTO grants Acurx Pharmaceuticals patent for DNA Polymerase IIIC inhibitors

Acurx Pharmaceuticals (NASDAQ: ACXP) has been granted a new patent by the U.S. Patent and Trademark Office (USPTO) covering DNA Polymerase IIIC inhibitors including compositions of matter, methods of use, and...

February 2, 2026

Developments

Publication supports scientific rationale for Palvella’s QTORIN in DSAP

Palvella Therapeutics (NASDAQ: PVLA) announced that Clinical and Experimental Dermatology has published a peer-reviewed systematic review synthesizing clinical evidence on off-label topical statin use in porokeratosis...

February 2, 2026

Developments

Kazia reveals compelling data on nuclear PD-L1 degrader NDL2

Kazia Therapeutics (NASDAQ: KZIA) has announced compelling preclinical and translational data supporting the development of NDL2, a potentially first-in-class protein degrader designed to selectively eliminate nuclear...

January 30, 2026

Developments

Immunotherapy review highlights Faron’s bexmarilimab in immune-resistant cancer

Faron Pharmaceuticals (AIM: FARN; First North: FARON) has announced the publication of a comprehensive review article in the peer-reviewed journal Immunotherapy detailing the potential of the company’s lead candidate...

January 29, 2026

Developments

OSE expands lusvertikimab into new immune-mediated indications

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) has announced that it has selected chronic pouchitis and hidradenitis suppurativa (HS) as new key indications for lusvertikimab, a potential first-in-class IL-7R...

January 29, 2026

Developments

FDA certifies LSL’s ophthalmic ointment manufacturing for U.S. market

LSL Pharma (TSXV: LSL) has announced that the FDA has certified the ophthalmic ointment manufacturing operations of its subsidiary, Steri-Med Pharma, clearing the company to commercialize ophthalmic ointment products in...

January 28, 2026

Developments

FDA grants En Carta BDD for EC Pocket Lyme test

Closely held En Carta Diagnostics has announced that its EC Pocket Lyme test for the early detection of Borrelia bacteria—the cause of Lyme disease—has received Breakthrough Design Designation (BDD) from the FDA. EC...

January 28, 2026

Developments

Omeros launches first commercial sales of YARTEMLEA for TA-TMA

Omeros (NASDAQ: OMER) has announced that it has completed its first commercial shipments of YARTEMLEA to distributors for the treatment of adult and pediatric patients with stem cell transplant-associated thrombotic...

January 27, 2026

Category - Developments

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