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…

Patritumab deruxtecan was unable to significantly improve overall survival in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations.

iTeos expects to absorb nearly $25 million in one-time costs for severance and termination payments. The biotech had 173 full-time employees at the end of 2024.

In a letter to the Department of Commerce, Novo Nordisk argued that unsanctioned compounded semaglutide, mostly from China, constitutes a national security threat to the U.S.

Whether you’re moving on or being moved out, how you leave can shape your reputation more than how you led.

The canceled contract comes as Moderna nears a critical FDA decision for its next-generation COVID-19 vaccine.

Nearly a third of employed and almost half of unemployed BioSpace survey respondents are seriously considering leaving the U.S. to find biotech and pharma jobs. Concerns about how the political climate is affecting biopharma are a key driver for many.

Drug Safety is a Key Priority at the Center for Drug Evaluation and Research

Weeks after shelving a TIGIT drug prospect, the biotech is seeking to sell off its assets and intellectual property in a bid to "maximize" shareholder value.

Passionate about the intersection of science and food, Olivia Haslam, deputy editor of NutraIngredients, started off as a chef, with a career continuing to revolve around the power of ingredients and storytelling.

Leerink Partners previews the drugs likely to be subject to the Inflation Reduction Act’s next price negotiations as the program expands to Medicare Part B and smaller biotechs.

Creatine and guanidinoacetic acid (GAA) supplementation may improve esports performance in experienced male gamers, according to new research.

A February executive order on pharmaceutical price transparency does nothing to change the incentives that keep costs opaque. But drug companies and other stakeholders would reap the benefits of such disclosures.

InflaRx’s vilobelimab met the bar for futility in a Phase III trial for the rare skin disease pyoderma gangrenosum.

In a video posted to social media on Tuesday, HHS Secretary Robert F. Kennedy, Jr. claimed that there is a lack of clinical data to support the repeat COVID-19 booster strategy in children.

The European Medicines Agency (EMA) is closed from 18:00 on Wednesday 28 May 2025 until 08:30 on Monday 2 June 2025.The product emergency hotline is available outside working…

Nearly two years in with Zurzuvae, Biogen tackles an ‘all of the above market’ to find patients and battle stigma in postpartum depression.

R&D spending across the global pharmaceutical sector climbed 1.5% in 2024, according to unreleased data from Evaluate Pharma.

List of Active RDRC Sites

The acquisition of SiteOne provides a bit of diversification for Lilly, which has burrowed into the obesity and diabetes space with mega-blockbuster tirzepatide and several follow-on molecules.

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.

Pharmavite recently unveiled its state-of-the-art $250 million gummy production facility in New Albany, Ohio. The massive investment, part of the company’s remarkable 90% growth since 2019, promises to produce billions of gummies annually while creating 225 new jobs.

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025

As the World Health Organization initiates a new agreement for coordinating global responses to future pandemics, the future of vaccine development in the U.S. faces growing challenges, including waning funding and regulatory changes, that threaten next-gen COVID-19 vaccine candidates and pandemic preparedness more broadly.

Beginning this week in Chicago, the American Association for Cancer Research’s annual conference will feature presentations that could have far-reaching implications for breast and blood cancers and more.

Information on patents and suitability petitions that impact the availability of generic drugs.

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

Information related to FDA’s preparation for the seventh reauthorization of PDUFA.

Find descriptions of some of the documents and actions, such as warning letters, recalls, Form 483 and inspection warrant, involved in DA oversight of compounding facilities.

The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule and over medication of children as reasons for chronic diseases.