United States. Food and Drug Administration
Dr. George Tidmarsh, the FDA's top drug regulator, has resigned after being accused of soliciting a bribe and tanking a company's stock as part of an alleged revenge plot against a former colleague, Kevin Tang. Tidmarsh was accused in a lawsuit of retaliating against Tang starting
United States. Food and Drug Administration
Anteris, a global structural heart company, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global Investigational Device Exemption (IDE) clinical trial, known as the PARADIGM Trial. This prospective randomized controlled trial will evaluate the safety and effectiveness of the DurAVR(R) Transcatheter Heart
United States. Food and Drug Administration
A new study published in the International Journal of Clinical Pharmacy has detected potential links between the use of proton pump inhibitors (PPIs) during pregnancy and reported adverse events, including premature labor, low birth weight, and prenatal complications. The research analyzed data from the US FDA Adverse Event Reporting System
United States. Food and Drug Administration
Scilex Holding Company, a revenue-generating company focused on non-opioid pain management products, has announced its sponsorship of the Dream Bowl 2026 and will distribute a meme coin, the Dream Bowl 2026 Meme Coin, to its shareholders. This digital collectible is intended to provide immutable recognition of ownership and utility with
United States. Food and Drug Administration
The US FDA's recent policy shift toward accepting non-animal alternatives for investigational new drug applications has sent shockwaves through the regulatory science community, according to a new study. The research, led by Bayer Pharmaceuticals, highlights the need for accelerated adoption of human-relevant new approach methodologies (NAMs) in targeted
United States. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has confirmed that Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements in the United States, marking a significant victory for the global longevity sector. This decision follows years of debate and industry pressure, and it clears the way for major
United States. Food and Drug Administration
Top drug regulator George Tidmarsh resigned Sunday from the Food and Drug Administration, amid scrutiny over his comments criticizing a treatment made by Aurinia Pharmaceuticals. Tidmarsh had been placed on administrative leave Friday after concerns were raised about his personal conduct. He had been at the FDA since July, overseeing
United States. Food and Drug Administration
Rein Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold on the Company's Phase 2 "RENEW" trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis (IPF). This decision follows a review of Rein's submission, which
Clinical trials
New patient-reported outcomes data from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant, a novel investigational PROTAC estrogen receptor degrader, demonstrated statistically significant improvements in overall quality of life, pain, and multiple functioning domains compared to fulvestrant in patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer. These findings
Clinical trials
A groundbreaking study published in Biometrics aims to revolutionize the approach to dose selection in clinical trials. The US Food and Drug Administration (FDA) has launched Project Optimus to shift the focus from the maximum tolerated dose to the optimal biological dose (OBD). This new approach seeks to optimize the
Colorectal cancer
Alphamab Oncology, a biopharmaceutical company, has made significant strides in its cancer treatment pipeline with the recent breakthrough therapy designation of its bispecific ADC, JSKN003, for advanced colorectal cancer (CRC). This marks the third breakthrough therapy designation for JSKN003, following its approvals for platinum-resistant ovarian cancer and gastric cancer. JSKN003
Colorectal cancer
Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. jointly announced that biparatopic HER2-targeting ADC JSKN003 has been granted another breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of HER2-positive advanced colorectal cancer (CRC) in patients who have failed
