Merck known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for clesrovimab (MK-1654), an investigational long-acting monoclonal antibody designed to protect infants from…
Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed following platinum-based chemotherapy. This designation…
Neurocrine Biosciences,has announced that the U.S. Food and Drug Administration (FDA) has approved CRENESSITY™ (crinecerfont) capsules and oral solution for use as an adjunctive treatment to glucocorticoid replacement in adults and pediatric patients aged four years and older with classic…
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This decision is based on promising data from the HERCULES Phase 3 study, which…
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…
