Regulatory Approval

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

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 a key FDA meeting set, Trevi Therapeutics pushes its drug Haduvio into late-stage trials, offering hope for millions with no approved treatments.

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

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

Palisade Bio's PALI-2108, a drug targeting IBD at its source, secures a key investment, offering hope for a new era of treatment with fewer side effects.

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?

Kelonia Therapeutics gets the FDA green light to expand trials for its in vivo CAR-T therapy, a single-infusion treatment that could redefine cancer care.

A new blood test in Western Canada promises to detect 59 cancers early. But with a high price tag and pending approval, it raises critical questions.

A routine prenatal screen can now detect a virus that causes birth defects, offering a path to prevention and sparking calls to change medical guidelines.

The first-ever Wegovy pill is here. Digital health firm eMed is partnering with Novo Nordisk to offer it, promising a new era of guided, responsible care.

A promising antiviral combination for Long COVID gets a major boost, accelerating its path to a pivotal clinical trial led by top researchers.

With its first drug for a rare disease now on the market, Stealth BioTherapeutics bets its future on a deep pipeline targeting mitochondrial dysfunction.

Health Canada greenlights an 8-week pill for acute HCV, a move experts say is a game-changer in the race to eradicate the virus by 2030.

With stunning clinical data for its miv-cel therapy, Kyverna is set to outline a new era for autoimmune treatment at the J.P. Morgan conference.

LENZ Therapeutics partners with Lunatus to launch its breakthrough VIZZ™ presbyopia eye drops in the Middle East, targeting a vast, unmet medical need.

Formerly Cybin, Helus Pharma's Nasdaq launch marks a pivotal shift towards commercializing its breakthrough depression and anxiety drug pipeline.

Gyre Therapeutics secures a pivotal conditional approval pathway in China for its novel liver fibrosis drug, offering hope for millions of hepatitis B patients.

A new drug could redefine life for polycythemia vera patients, replacing frequent, burdensome blood draws with a simple weekly self-injection.