Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against ...

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. The online application makes it possible to ...

Dublin, Sept. 18, 2025 (GLOBE NEWSWIRE) -- The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Oct 20th - Oct 21st, 2025)" training has been added to ...

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.

Ceruvia Lifesciences, a biopharmaceutical company, announced that it has produced the world's first LSD that meets stringent "Current Good Manufacturing Practices" (CGMP) standards required by the FDA ...

AI refers to a machine-based system and ML refers to a set of techniques that can be used to train AI algorithms (2) so ML ...

FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...

SHANGHAI, Jan. 16, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. ('OBiO', 688238.SH), a gene and cell therapy-focused contract research organization (CRO) and contract development and ...

A prenatal vitamin is a multivitamin that is specially formulated to offer the key nutrients that both babies and mothers need during pregnancy.

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Celltrion for good manufacturing practice (GMP) issues at the site where it produces its Remicade biosimilar, Inflectra ...

In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over ...