Regulatory Approval

LiviWell's Livi device, the first of its kind, gets FDA clearance to absorb post-sex fluids, aiming to improve comfort and vaginal health.

The CRDMO giant posted a 16.7% revenue jump in 2025, driven by a massive pipeline expansion and a strategic pivot to next-generation biologics.

A new platform is launching to connect pharma companies directly with 70+ global regulators, promising to slash approval times and speed patient access.

With positive safety data for its novel UC drug, a €530M cash reserve, and a new commercial chief, Abivax is poised for a major market entry.

With over AUD$1M in sales from its first MDMA batch, Cortexa is validating Australia's pioneering move to legalize psychedelic-assisted therapy.

Telehealth platforms like ReflexMD offer cheaper, compounded GLP-1s for weight loss. But what are the risks, and what do consumers need to know?

With 17 abstracts at AAD 2026, LEO Pharma showcases real-world data to tackle treatment gaps in diverse populations and chronic skin diseases.

IntraBio's landmark FDA submission for levacetylleucine offers the first glimmer of an approved therapy for the devastating rare disease Ataxia-Telangiectasia.

An influential guidelines update expands options for a tough-to-treat bladder cancer, giving patients access to a novel gene therapy beyond its FDA label.

A new book by a top physician-scientist challenges the idea that innovation comes from the private sector, arguing Medicaid is a lab for bold experiments.

A new AI tool promises to help doctors solve complex cases where lab tests are normal, using 'causal reasoning' to find the root cause of illness.

With pivotal trials advancing, key FDA alignment, and a strong cash position, Taysha Gene Therapies charts a clear path toward a potential breakthrough.

Ractigen's RAG-01 advances with NMPA approval, using RNA activation to fight bladder cancer by targeting a previously 'undruggable' gene.

Belief BioMed's single-dose treatment for hemophilia B, BBM-H901, is now approved in Macao, offering a new horizon for patients beyond frequent injections.

JenaValve's Trilogy system gains historic FDA approval, offering a new, minimally invasive option for high-risk patients with a life-threatening heart condition.

InflaRx announces a late-breaking presentation on its Phase 3 trial for vilobelimab, offering potential new hope for pyoderma gangrenosum patients.

The FDA grants PolyPid a crucial $4.3 million fee waiver for its D-PLEX₁₀₀ drug, freeing up vital cash to accelerate its commercial launch.

Aldeyra Therapeutics' dry eye drug, reproxalap, was rejected by the FDA for a third time, citing inconsistent data and wiping out millions in value.

A simple blood test is revolutionizing Alzheimer's diagnosis. ALZpath's pTau217 antibody is now the industry benchmark, promising earlier detection for millions.

A new compound could make CAR-T cell therapy more durable and less costly, showing promise against both cancer and HIV in groundbreaking new research.