Regulatory Approval

Parnell’s nixiFLOR, the first generic of Resflor Gold®, offers a cost-effective new weapon for ranchers battling Bovine Respiratory Disease.

A stark new benchmark study reveals poor survival in late-stage GvHD, just as MaaT Pharma’s microbiome therapy shows dramatically better outcomes.

The biopharma firm touts transformative drug data ahead, but with cash for only month-to-month operations, its future hangs by a precarious thread.

With FDA approval, soaring revenues, and game-changing clinical data, InspireMD prepares to spotlight its CGuard Prime stent for investors this April.

Serenity Medical's River stent is a landmark approval for severe IIH, a condition causing chronic pain and vision loss, primarily in young women.

With its lead drug for a rare pediatric liver disease entering late-stage trials, NorthSea Therapeutics adds a veteran drug developer to its board.

A new, non-invasive therapy for men offers a faster, FDA-cleared, and Medicare-covered path to regaining bladder control after prostate surgery at home.

A new, imageable liver cancer therapy is one step closer to patients, thanks to a strategic partnership securing a vital US-based medical isotope supply.

A key U.S. patent extends protection for a promising CRPS-1 drug, paving the way for a potential first-in-class treatment for the debilitating condition.

A new partnership provides early access to an investigational drug for FAP, offering a potential non-surgical therapeutic option for the first time.

A new, highly selective oral drug for the most common form of dwarfism has been cleared for U.S. trials, offering hope for a more convenient treatment.

Tenpoint Therapeutics launches YUVEZZI, a once-daily drop for presbyopia, entering a fierce market with a novel two-in-one formula for aging eyes.

A new drug not only reduces osteoarthritis pain significantly but may also be the first to modify the disease itself, a landmark study in The Lancet reveals.

Aurinia Pharmaceuticals' deal for Kezar Life Sciences hinges on zetomipzomib, a promising but risky drug poised to tackle a rare autoimmune liver disease.

The massive C$5.15 billion deal transforming Plains into a crude oil pure-play and Keyera into an NGL giant faces a delay amid a Competition Bureau review.

After a transformative year with key FDA/EU approvals, Pulsenmore's financials get a one-time boost. Can it now conquer the remote prenatal care market?

LIB Therapeutics' new monthly, room-temperature stable cholesterol drug shows strong long-term data, challenging rivals with a focus on patient ease-of-use.

Australian medtech firm 4DMedical lands CE Mark for its revolutionary CT:VQ lung imaging, fueling a major European expansion with a fresh AU$83M investment.

A $15M grant fuels a revolutionary therapy for a fatal childhood disease, turning patients' own cells into 'living biofactories' to fight MPS I.

As millions grapple with Cannabis Use Disorder, a small biotech's lead drug enters Phase 3 trials, promising the first-ever FDA-approved treatment.