Category - Developments

Developments

FDA grants Sonoma 510(k) clearance for Microdacyn Wound Irrigation Solution

Sonoma Pharmaceuticals (NASDAQ: SNOA) has received a new 510(k) clearance from the FDA for its Microdacyn Wound Irrigation Solution, including expanded claims, clearance for multiple use, and additional packaging...

June 30, 2026

Developments

Pasithea reports positive interim Phase 1 cancer study data

Pasithea Therapeutics (NASDAQ: KTTA) has announced updated interim safety and clinical activity data from its ongoing first-in-human trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a...

June 30, 2026

Developments

Sunshine receives Canadian regulatory approval for generic Anastrozole tablets

Sunshine Biopharma (NASDAQ: SBFM) has announced the approval of its generic Anastrozole tablets of 1mg for the treatment of postmenopausal women with hormone receptor-positive breast cancer in the Canadian market...

June 25, 2026

Developments

AFRRI/NIAID designs PBI-BM2.5 protocol to evaluate Valion’s Entolimod for GI-ARS

Valion Bio (NASDAQ: VBIO) has announced that the Armed Forces Radiobiology Research Institute (AFRRI), in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), has completed design of the...

June 25, 2026

Developments

REGENXBIO completes dosing in study of RGX-202 in DMD

REGENXBIO (NASDAQ: RGNX) has completed dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy (DMD). According to REGENXBIO, this milestone positions the...

June 24, 2026

Developments

BioMark Diagnostics receives CIPO and EPO patent allowances for early-stage lung cancer blood test

BioMark Diagnostics (CSE: BUX; FSE: 20B; OTCQB: BMKDF) has announced the receipt of patent allowances from both the Canadian Intellectual Property Office (CIPO) and the European Patent Office (EPO) for its...

June 23, 2026

Developments

Zevra highlights publication of positive data from study of MIPLYFFA in NPC

Zevra Therapeutics (NASDAQ: ZVRA) has announced the publication of data suggesting that MIPLYFFA (arimoclomol) was well tolerated in pediatric patients with Niemann-Pick disease type C (NPC) in the peer-reviewed journal...

June 23, 2026

Developments

FDA grants Prime RMAT for PM359 in CGD

Prime Medicine (NASDAQ: PRME) has announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PM359, an investigational autologous Prime Edited hematopoietic stem cell therapy for the...

June 22, 2026

Developments

Transgene expands platform with trial of INTV in NSCLC

Transgene (Euronext Paris: TNG) has initiated a Phase 1 trial evaluating its Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, TG4070, from its myvac platform, in combination with nivolumab, in the...

June 22, 2026

Developments

USPTO grants Clearmind patent for binge behavior regulators

Clearmind Medicine (NASDAQ: CMND) has been granted a U.S. patent titled “BINGE BEHAVIOR REGULATORS”, by the United States Patent and Trademark Office (USPTO). The patent, which refers to Clearmind’s molecule MEAI (5...

June 19, 2026

Category - Developments

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