Associations
The International Collaboration on Cosmetics Safety (ICCS) has welcomed the Consumer Healthcare Products Association (CHPA) as its newest member, joining a global network dedicated to advancing animal-free safety assessments for cosmetics and personal care products. As the Food and Drug Administration emphasizes the need for reliable alternatives to animal testing,
Protein preparations
A recent investigation by Consumer Reports found that over two-thirds of protein powders tested contained unsafe or concerning levels of lead, with some products having lead levels 13 times higher than the recommended daily limit. This is particularly alarming in plant-based products, which showed higher levels of lead compared to
Associations
Food and Drug Administration (FDA) has intensified its efforts to inspect drug manufacturing units operating in the state after a toxic syrup incident claimed the lives of several children in Chhindwara. The agency is also gearing up to implement instructions issued by Deputy CM and Health Minister Rajendra Shukla during
Associations
The Alzheimer's Association welcomes the Food and Drug Administration (FDA) clearance of the Elecsys pTau181 plasma test, developed by Roche, marking the first blood-based biomarker test for Alzheimer's disease cleared for use in the primary care setting to rule out the presence of amyloid pathology. This
Associations
Arvinas, Inc. has announced that new data from the Phase 3 VERITAC-2 clinical trial will be presented at the European Society for Medical Oncology (ESMO) Congress, scheduled to take place from October 17 through 21, 2025, in Berlin, Germany. The data will focus on patient-reported outcomes (PROs) for vepdegestrant, a
Associations
The U.S. Food and Drug Administration (FDA) has cleared the Elecsys pTau181 plasma test, developed by Roche, as the first blood-based biomarker test for Alzheimer's disease for use in primary care to rule out amyloid pathology. This new diagnostic tool can significantly improve the diagnostic process by
Vaccines
The New Mexico Department of Health has implemented a standing order to provide the latest COVID-19 vaccines to anyone 6 months and older without a prescription, following widespread confusion about access to the vaccine due to inconsistent federal guidance. The order, signed by Dr. Miranda Durham, chief medical officer, serves
Securities law
Soleno Therapeutics, a biopharmaceutical company, has filed a Form 8-K with the U.S. Securities and Exchange Commission, reporting a serious adverse event involving a patient who has passed away while taking VYKAT XR. The patient, a 17-year-old male with a history of co-morbidities, died from an apparent pulmonary embolus.
Securities law
Travere Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has informed the company that an advisory committee is no longer needed for the supplemental New Drug Application (sNDA) for Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS). The sNDA remains under review by the FDA with
Securities law
Faruqi & Faruqi, LLP is investigating potential claims against Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ: REPL) and reminds investors of the September 22, 2025 deadline to seek the role of lead plaintiff in a federal securities class action. The complaint alleges that the Company
Vaccines
Alzinova AB, a biotech company, has secured approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for its planned Phase II clinical study with the vaccine candidate ALZ-101 in Alzheimer's disease. This approval marks a significant milestone for the company, enabling
COVID-19
Shionogi Inc. has made significant progress in the development of an oral antiviral medication for COVID-19 prevention, submitting a New Drug Application (NDA) to the U.S. FDA for ensitrelvir fumarate. The FDA has accepted the NDA and set a target date for completion of the review (PDUFA date) as
