Category - Developments

Developments

CervoMed completes enrollment for study of neflamapimod in nfvPPA

CervoMed (NASDAQ: CRVO) has announced that it has completed enrollment in the Phase 2a study to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in patients with nonfluent/agrammatic variant...

July 9, 2026

Developments

First patient dosed in Delcath’s global trial of HEPZATO in mBC

Delcath Systems (NASDAQ: DCTH) has announced that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy, in its global Phase 2 clinical trial evaluating HEPZATO in combination with...

July 9, 2026

Developments

MAIA reports strong data from trial of 3L therapy in NSCLC

MAIA Biotechnology (NYSE American: MAIA) has announced positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action...

July 9, 2026

Developments

FDA grants RPDD to Vanda’s investigational CMT2S therapy

Vanda Pharmaceuticals (NASDAQ: VNDA) has announced that the FDA has granted Rare Pediatric Disease Designation (RPDD) to its investigational antisense oligonucleotide therapy—VCA-894A—for the treatment of Charcot-Marie...

July 8, 2026

Developments

FDA accepts Organogenesis’ ReNu BLA for knee OA

Organogenesis Holdings (NASDAQ: ORGO) has announced that the FDA has accepted for review its Biologics License Application (BLA) for ReNu, a cryopreserved, amniotic suspension allograft developed for the treatment of...

July 7, 2026

Developments

Alligator highlights first patient dosed in trial of mitazalimab in breast cancer

Alligator Bioscience (STO: ATORX) has announced that the first patient has been dosed in an investigator-led trial evaluating the intratumoral administration of mitazalimab, the company’s lead CD40 agonist, in patients...

July 2, 2026

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

Category - Developments

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