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…

Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.

Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.

With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.”

The Bristol Myers-partnered bispecific antibody kept small cell lung cancer under control in participants enrolled in a Phase 2 trial.

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.

Health Canada and the Public Health Agency of Canada have conducted a broad review of regulations and program administration to identify outdated, inefficient or duplicate regulations that hinder economic growth and create unnecessary burden for businesses and people in Canada.

The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.

The companies said their updated shot spurred an increase in neutralizing antibodies against currently circulating strains, answering calls for more corroborating evidence.

Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.

The Trump administration enacted tariffs against India 10 days ago that will impact the country’s botanical sector.

New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.

Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.

The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perio

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.

Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies, which founded Lykos, bemoaned a “moving of the goal posts” in Lykos’ rejection but looked for positives in the newly released complete response letter.

Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed.

The FDA also unveiled a batch of 89 previously unpublished complete response letters, including rejection notices to Capricor and Replimune.

The data presented in the Canada Vigilance Adverse Reaction Online Database has been updated and now includes information received by Health Canada up to May 31, 2025. The next update of data is scheduled for early October, 2025.

In this episode, listeners will learn about the rigorous ingredient selection process for Herbalife’s MultiBurn, how trademark ingredients drive innovation, Herbalife’s commitment to scientific integrity, ethical practices and more.

PlantFusion expands its sustainable product reach with a national launch at Whole Foods, introducing BPI-certified compostable packaging to eco-conscious consumers and reinforcing its commitment to sustainability and plant-based nutrition.

Sahar Berjis, a nationally-recognized registered dietitian, nutrition coach and CEO talks about NAD+ and why supplementing with the molecule can boost overall health.

Led by the former CEO of Hi-Bio and backed by notable investors, the startup licensed from Hengrui a drug it claims is superior to Bristol Myers' Camzyos as well as other, similar medicines.

The UK government is consulting on banning high-caffeine energy drinks for under-16s, citing health risks like anxiety, poor sleep and reduced academic performance. However, new research suggests that lifestyle factors—not caffeine alone—may be the real driver of cardiovascular risk in adolescents, raising questions about the proposed ban.

Ousted CDC Director Susan Monarez claimed in an op-ed published in The Wall Street Journal Thursday that she was fired for refusing to rubber-stamp COVID-19 recommendations to be made by an advisory panel that has expressed “antivaccine rhetoric.”

Despite hitting its efficacy targets in the Phase III COAST-1 study, Sanofi’s amlitelimab remains “meaningfully inferior” to Dupixent, according to analysts at Leerink Partners.

Hengrui Pharmaceuticals has been busy this year, signing a nearly $2 billion cardio contract with Merck in March and a 12-asset agreement with GSK in July worth up to $12 billion.

In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”

Review will assess risk of leukoencephalopathy, a condition affecting the brainEMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in…, Agenda Agenda of the PRAC meeting 1-4 September 2025DraftReference Number: EMA/PRAC/234907/2025 English (EN…, PRAC statistics: September 2025 , PRAC statistics: September 2025 English (EN) (33.17 MB – PDF)First published: 05/09/2025View, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Robert F. Kennedy Jr. faced criticism Thursday even from Republican lawmakers over changes to federal vaccine policy as well as a leadership crisis at the CDC.

The venture firm has closed its third "Opportunity Fund,” which complements its early-stage work by supporting startups it's already backed.