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…
Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752), which is studying twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV…
Last fall, the Food and Drug Administration (FDA) recommended discontinuing the use of oral phenylephrine in over-the-counter (OTC) cold and cough products due to concerns over its effectiveness. This decision has raised questions about which phenylephrine products are affected and…
Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company fully owned and operated as a subsidiary of Bayer AG, announced that its investigational gene therapy, AB-1003 (also known as LION-101), has been granted both Rare Pediatric Disease and Orphan Drug designations…
The Access and Allocation Mechanism (AAM) for mpox has allocated an initial 899,000 vaccine doses to nine African countries severely impacted by the ongoing mpox outbreak. This distribution, made in collaboration with affected nations and donors, aims to ensure effective…
Libra Therapeutics, Inc., a private biotechnology company focused on developing innovative therapies to restore cellular balance and reduce neurodegeneration, has announced the appointment of Shawn A. Scranton, PharmD, as President and Chief Executive Officer. Dr. Scranton brings 30 years of…
Exelixis, Inc. (Nasdaq: EXEL) released its third-quarter financial results for 2024 and highlighted recent progress across key commercial, clinical, and pipeline milestones. Key Developments and Corporate Updates Pipeline and Clinical Trials Cabozantinib Franchise Revenue: The cabozantinib franchise generated $478.1 million…
Dr. Reddy’s Laboratories Ltd. has been recognized as one of the top employers in the 2024 Top Biotech and Pharma Employers Survey conducted by Science magazine, marking the company’s third consecutive year on the prestigious list. In the 2022 survey,…
