Category Regulatory

Senegal and Rwanda have joined an elite group of African nations by achieving Maturity Level 3 (ML3) status in the World Health Organization’s (WHO) global classification of national regulatory authorities. This milestone reflects their dedication to providing safe, effective, and…

Applied Therapeutics, the biopharmaceutical company focused on developing treatments for rare diseases, recently received a warning letter from the U.S. Food and Drug Administration (FDA) following concerns raised about the conduct of its clinical trial for govorestat. The letter, issued…

Merck known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC)…

Intra-Cellular Therapies has submitted a supplemental New Drug Application (sNDA) to the FDA for its drug Caplyta (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults. The approval of this indication could potentially add over $1 billion in…

Despite criticism stemming from contentious biomarkers and failed confirmatory trials, the FDA’s accelerated approval pathway continues to drive therapeutic innovation for some of the world’s most complex and pressing medical challenges. A History of Impact Introduced in 1992 during the…

BridgeBio Pharma, Inc. announced the FDA approval of Attruby™ (acoramidis), an oral stabilizer of transthyretin (TTR), for adults with transthyretin amyloid cardiomyopathy (ATTR-CM). This treatment aims to reduce cardiovascular death and hospitalization, based on positive results from the ATTRibute-CM Phase…

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL injection. This intravenous treatment is for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC). Approval…

Astellas Pharma Inc. (TSE: 4503) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on November 15, 2024, regarding the supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution). The sNDA aimed…

Astellas Pharma Inc. (TSE: 4503) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution) for geographic atrophy (GA) secondary to…

The United Nations Climate Change Conference (COP29) in Baku achieved a pivotal advancement in aligning health and climate agendas. Building on commitments from previous COPs, this year’s conference emphasized tangible action to safeguard global health amidst the growing challenges of…

BridgeBio Pharma, Inc. (Nasdaq: BBIO), a biopharmaceutical company focused on genetic diseases, has announced positive interim results from the ATTRibute-CM open-label extension (OLE) study of acoramidis, presented at the American Heart Association (AHA) Scientific Sessions. Acoramidis, an investigational small molecule…