60 Degrees Pharma received IRB approval for an expanded access study of tafenoquine to treat persistent babesiosis in immunocompromised patients.

X4 Pharmaceuticals' Marketing Authorization Application (MAA) for mavorixafor to treat WHIM syndrome is under EMA review, potentially the first EU-approved drug for the condition.

The FDA has approved Protega Pharmaceuticals' Roxybond 10mg for managing severe pain when alternative treatments are inadequate.

• Camber Pharmaceuticals has announced the launch of Temozolomide Capsules, USP, an alkylating drug used in the treatment of glioblastoma and anaplastic astrocytoma in adults. • The medication will be available in five different strengths (5mg, 20mg, 100mg, 140mg, 180mg, and 250mg) and in various count options to support different treatment regimens. • Temozolomide is primarily used as a concurrent treatment with radiotherapy for newly diagnosed glioblastoma patients, followed by maintenance therapy, addressing critical needs in brain cancer treatment.

Reviva Pharmaceuticals has announced encouraging preliminary data from its Open-Label Extension (OLE) study for brilaroxazine, showing favorable safety, tolerability, and adherence rates. The company is gearing up for its confirmatory Phase III RECOVER-2 trial, with plans to launch in early 2025. Additionally, Reviva has successfully raised $18 million to fund the upcoming trial and support operations until approval.

Meitheal Pharmaceuticals has received FDA approval and launched liraglutide injection (18mg/3mL), a generic equivalent of Victoza, providing a new treatment option for type 2 diabetes patients amid ongoing shortages.

Vanda Pharmaceuticals has accused FDA officials of unlawfully delaying a hearing on its gastroparesis drug tradipitant, claiming the agency is using recent staff reductions as a false excuse for a six-month postponement.

Phio Pharmaceuticals Corp. (PHIO) experienced a significant stock surge of +383.16% following the announcement of promising results from its Phase 1b clinical study of PH-762, a cancer treatment drug. The study showed complete tumor clearance in two out of four patients, with no serious side effects reported, highlighting the potential of Phio's INTASYL® siRNA gene silencing technology in revolutionizing cancer treatment.

The FDA granted Fast Track Designation (FTD) to 64Cu-SAR-bisPSMA for PET imaging of prostate cancer lesions in patients with biochemical recurrence after definitive therapy.

Jazz Pharmaceuticals is strategically diversifying its portfolio beyond sleep disorders, enhancing its resilience and growth potential.

enGene Holdings Inc. has appointed Dr. Raj Pruthi as Senior Vice President, Urologic Oncology and Clinical Development, to support the advancement of EG-70.

Ignite Proteomics launches a novel precision oncology assay using Reverse Phase Protein Array (RPPA) technology for breast cancer treatment decisions.

Theralase Technologies announced a 61.9% complete response rate in its Phase 2 bladder cancer study, with a 43.6% duration of response at 450 days.

Galera Therapeutics settled a lawsuit against Alira Health Clinical and IQVIA Biotech regarding a statistical error in the Phase 3 ROMAN trial.

Acelyrin's lonigutamab demonstrated clinically meaningful improvements in Thyroid Eye Disease (TED) symptoms, including proptosis, CAS, and diplopia, in Phase 2 trials.

Acelyrin's izokibep demonstrated high statistical significance in meeting the primary endpoint of ACR50 at week 16 versus placebo in a Phase 2b/3 trial for psoriatic arthritis.

COSCIENS Biopharma shifts focus to natural-based products after its Phase 3 DETECT trial for macimorelin in Childhood Growth Hormone Deficiency (CGHD) failed.

The FDA has approved a labeling change for Biktarvy, an HIV-1 treatment, based on new clinical data.

Kymera Therapeutics reported $10.3 million in revenue, primarily from its collaboration with Sanofi, and holds a strong cash balance of $745 million, expected to last into the first half of 2027.

Matinas BioPharma's MAT2203, an oral formulation of amphotericin B, demonstrates enhanced survival and reduced fungal burden in preclinical studies.