Regulatory Approval

Alessa Therapeutics’ rice-sized implant, Enolen, earns FDA Fast Track, promising a new era for prostate cancer therapy without debilitating side effects.

Record AI mega-deals redefine healthcare innovation, yet a broader market contraction creates a new divide for startups and traditional medical sectors.

The diagnostics firm's new offering combines sample collection with CRO and CDMO services, aiming to slash timelines and reduce regulatory risk for developers.

With key studies now complete, Biofrontera's light-based therapy Ameluz could soon offer a new weapon against widespread actinic keratosis and stubborn acne.

A new class of painkillers promises the power of opioids with a far lower risk of addiction. Tris Pharma's cebranopadol could reshape pain management.

A new study on oral testosterone therapy for men 65-80 could reshape geriatric care, challenge FDA guidelines, and unlock a multi-billion dollar market.

Safi Biotherapeutics and ARMI | BioFabUSA achieve a critical step toward mass-producing red blood cells, offering hope for patients and military readiness.

A new national reimbursement code for NeurAxis's IB-Stim therapy is set to revolutionize access for chronic GI pain patients, validating the technology.

858 Therapeutics' novel PARG inhibitor offers new hope for patients with a deadly, drug-resistant form of ovarian cancer, accelerating its path to approval.

With record growth and a fortified cash position, ElevateBio combines AI-driven discovery and industrial-scale manufacturing to power the gene therapy boom.

A new vectorized antibody therapy for ALS, VTx-002, has been granted FDA Fast Track status, accelerating its path to patients battling the disease.

China approves Aizhida, a novel once-daily ADHD medication. Its unique dual-action formula provides rapid and sustained symptom control, aiming to transform treatment.

After success in Europe, Allotex gets FDA nod to begin U.S. trials for its tissue-based presbyopia treatment, offering new hope for millions.

Acertis Pharmaceuticals secures rights to Licart, a unique once-daily NSAID patch, aiming to disrupt the competitive U.S. topical pain relief market.

Employer health plans are using 'alternative funding' to cut costs, but critics warn these schemes force patients to use risky, non-FDA approved drugs.

Scientists unveil a DARPA-funded biofilm that may expel 98% of ingested microplastics, offering a new defense in the fight for human health.

A biotech firm's promising concussion therapy, backed by NFL's Alex Smith, shows an 85% responder rate and now seeks public funding for its final push.

A new tri-specific antibody, IM1240, safely hits cancer cells at massive doses in preclinical studies, potentially solving a key toxicity problem in immunotherapy.

Vera Therapeutics' novel IgAN drug gets FDA fast-track review, promising a new at-home treatment for a debilitating autoimmune kidney disease.

With a device that calms deadly 'cytokine storms,' SeaStar Medical targets vast new markets, but can the small company deliver on its huge promises?