News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.

The sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues.

Led by former founders of a biotech AstraZeneca acquired in 2023, AllRock Bio is starting out with a drug licensed from Sanofi that’ll be tested against pulmonary arterial hypertension.

The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing.

Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.

Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.

mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.

FDA alerts of risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.  

mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.

Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.

FDA alerts of risks with use of unauthorized infant monitoring devices, which have not been reviewed for safety and effectiveness.

Opening Remarks by Grace Graham at the FDA Online Controlled Substances Summit, Washington, D.C.
September 11, 2025

Speech by
Grace Graham
Deputy Commissioner for Policy, Legislation, and International Affairs – Food and Drug Administration
FDA Online Controlled Substances Summit

In the age of GLP-1s, supplement companies face additional complexities on what they can and cannot say about weight management claims.

Novartis and Monte Rosa first partnered in October 2024 for a molecular glue asset for immune-mediated and autoimmune diseases. This time, the pharma is putting $120 million down upfront for more of the biotech’s AI-discovered degraders.

CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific drug applications were redundant, but then denied having said the agency would abandon them.

A depleter of pathogenic T cells, rosnilimab’s novel MOA generated a differentiated efficacy, tolerability and safety profile in recent Phase 2b study

While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss.

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc

t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin.

t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin.

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.

Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Your best defense is vaccination, which provides important protection from flu and its potential complications.

Insights from CDER leadership and experts on public health actions

The U.S. Food and Drug Administration (FDA) has developed a Pilot Grant Program to support the development of publicly available core set(s) of Clinical Outcome Assessments (COAs) and their related endpoints for specific disease indications (RFA-FD-19-006).

Rhonda Pacheco, who oversaw Zepbound’s launch, will run Takeda’s U.S. business. Elsewhere, early data suggested Maze might have a “best-in-class” rare disease drug and Arrowhead challenged Ionis in court.

Once dominated by a few established brands that relied on high-sugar, high-caffeine formulas for an energy boost, today’s energy drink market is larger, more fragmented and healthier than the energy drinks we saw in the early 2000s.

Early academic research suggests various ways weight loss drugs could have an impact in cancer care.

Skin Moderne has launched a new nutricosmetic supplement, i/O Beauti, targeting the gut-skin axis and cellular health, marking its entry into the beauty-from-within category. The formulation includes two key ingredients, CoreBiome and Yüth, chosen for their systemic health benefits, including gut barrier integrity and mitochondrial health. CEO Richard Purvis emphasizes the scientific backing and research-driven approach behind these ingredients, moving away from traditional supplements like collagen. The brand aims to educate consumers on the benefits of this innovative approach to beauty and wellness.

A wave of state laws aiming to ban certain chemicals from the food supply and create greater transparency in how additives are approved is reshaping the regulatory landscape and placing new scrutiny on FDA’s GRAS (Generally Recognized as Safe) system.

Researchers from the University of Novi Sad conducted a study on the effects of low-dose creatine hydrochloride and ethyl ester on perimenopausal and menopausal women, focusing on cognitive function and metabolic changes. The study, funded by Vireo Systems and Serbia’s Provincial Secretariat, found that an eight-week regimen of creatine hydrochloride, with or without creatine ethyl ester, improved cognition, increased brain creatine levels, and modulated serum lipid profiles without significant side effects.