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A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential future impacts for gene therapy regulation and market access.

The acquisition will bring Vicebo's Molecular Clamp technology under Sanofi's umbrella.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, highlights Emrelis’ potential to broaden its clinical impact by expanding into other solid tumors with high c-MET overexpression, beyond its current focus on non-small cell lung cancer.

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to strengthen FDA’s drug review and innovation efforts.

Regulators failed to halt production and importation of illegal GLP-1 compounds.

A special live broadcast of award-winning star and CEO’s conversation will focus on advancements and regulations on ALS sciences.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Emrelis marks a pivotal moment for ADC therapies in oncology, reflecting the FDA’s growing confidence in their safety and efficacy and accelerating the shift toward precision medicine in cancer treatment.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.

The MC4R agonist targets rare genetic and hypothalamic obesity, with potential as a combination or maintenance therapy for general obesity alongside GLP-1 agents.

The therapy initiation partner will integrate the service provider’s technology platform to its national network.

Amphix Bio leads breakthrough of regenerative spinal cord injury treatment.

The submission is supported by four Phase III clinical trials, which showed that icotrokinra demonstrated significant skin clearance in patients with moderate to severe plaque psoriasis.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, discusses how Emrelis fits into the current antibody-drug conjugate landscape and what distinguishes its approach in biomarker-driven oncology.

Waterdrop’s advancements in AI technology earned the company a place in the collection.

Studies presented at the Society of Neurointerventional Surgery’s show links between GLP-1s and the prevention of strokes and reductions in brain injury complications.

The deep learning model increases handheld 3D medical imaging access.

Corina Dutcus, SVP, oncology global clinical development lead at Eisai, discusses the potential of the E7386 and lenvatinib combination to address unmet needs in second-line treatment for endometrial carcinoma patients.

The direct-to-patient payment option is a resource for Eliquis patients to lower out-of-pocket costs and increase accessibility.

The games are designed to promote activities that exercise the brain.

The newly approved prefilled syringe version of Shingrix is expected to simplify administration and supports efforts to increase adult vaccination against shingles (herpes zoster).

Priority review was based on results from the Phase IIb SunRISe-1 trial, which showed that patients treated with TAR-200 for high-risk non-muscle invasive bladder cancer showed a complete response rate of 82.4%.

The reality TV star and certified obesity physician Dr. Holly Lofton plan to use the show to further educate GLP-1 users on potential side effects.

Research from a recent Cadent study reveals the growing impact of TV and connected TV advertising in raising medication awareness across diverse demographic groups, highlighting shifting dynamics in how patients discover treatment options.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, explains how E7386 and lenvatinib work together to target advanced endometrial carcinoma through dual mechanisms of action and WNT pathway modulation.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, highlights how long-term LEAP-002 data provides critical reassurance around Lenvima’s durability and safety in treating unresectable hepatocellular carcinoma.

Executives who treat capital allocation as a CEO-level strategic discipline are best positioned to thrive in a volatile and increasingly capital-constrained environment.

Alliance Pharmaceuticals plans to use the new to attack counterfeiters rather than just defend against them.

Leqselvi are currently available 8 mg tablets for severe Alopecia Areata treatments in adult patients.

Preclinical study shows oral PL7737 agonist outperforms tirzepatide alone in rodent models, supporting Palatin’s plans for clinical trials targeting both general and rare forms of obesity.