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…

The star of the acquisition, which includes a contingent value right of $6 per share, is pegozafermin, an FGF21 analog in late-stage development for metabolic dysfunction-associated steatohepatitis.

Supporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is an “improving” regulatory environment for non-addictive options for chronic pain, according to analysts at Jefferies.

In this deep dive, BioSpace explores the next big thing in obesity.

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues

Withdrawn and Expired Guidances | Drugs

During a hearing in front of the Senate’s HELP committee, Susan Monarez addressed her controversial firing and recalled a conversation where Health Secretary Robert F. Kennedy Jr. allegedly said that “CDC employees were killing children and they don’t care.”

Listen now for a high-level discussion on overcoming pharmaceutical supply chain challenges through end-to-end integration.

Susan Monarez told Senators at a hearing Wednesday that Robert F. Kennedy Jr. pushed her out for refusing to rubber-stamp changes.

Moving forward, Innate will focus on the clinical development of its antibody-drug conjugate IPH4502, the lymphoma candidate lacutamab and the AstraZeneca-partnered monalizumab.

In letters to Eli Lilly and Novo Nordisk, the FDA accused the companies of downplaying the risks of their GLP-1 weight loss drugs during a prime time special with Oprah Winfrey.

Nature’s Way has invested over $12 million in a geothermal project to enhance sustainability by reducing carbon emissions by 20%. The initiative involves drilling 280 wells, each 500 feet deep, to maintain a stable temperature for operating HVAC systems, eliminating the need for five chillers and six boilers. This project aligns with the company’s commitment to supporting nature and sustainability, a value strongly endorsed by its parent company, Schwabe Group. Completion is expected by the third quarter of 2026, reflecting Nature’s Way’s dedication to environmental responsibility and community welfare.

A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.

The multi-billion, multi-year investment comes as many of GSK’s pharma peers pull away from the U.K., either suspending or completely canceling previous commitments.

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking

A deal with Dutch startup VarmX gives CSL an option to buy a Phase 3-ready drug that could reverse the effects of popular anticoagulants like Eliquis, which carry the risk of internal bleeding.

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.

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.

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.  

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.