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…

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued…

FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs.

Bloom Pop is also built on the prior success of Bloom Sparkling Energy, introduced in July 2024.

CGMP/Finished Pharmaceuticals/Adulterated

After the FDA rejection of Zurzuvae in one type of depression and the triple failure of neuro asset dalzanemdor, Sage was searching for a path forward at the end of December 2024. Biogen CEO Chris Viehbacher spied a possible deal, but the smaller company wasn’t interested.

Bioinformatics is on the rise, forecasted to grow by about $16 billion from 2024 to 2029 given its value to managing mass datasets critical to modern drug discovery and development. Two talent acquisition experts share how the field has evolved in the past few years and which skills are most in demand.

Lawyers, regulators and industry stakeholders convened last week at the New York City Bar Association for the 13th Annual ACI-CRN Legal, Regulatory and Compliance Forum on Dietary Supplements to discuss compliance strategies in a broader regulatory landscape that is perhaps overwhelmed by movement and underwhelmed by nuance.

Novartis is falling farther behind AbbVie, which expanded its JAK inhibitor Rinvoq into giant cell arteritis in April.

Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are at risk of severe disease.

Over 75% of infants in the U.S. are deficient in Bifidobacterium – bacteria once a cornerstone of U.S. infants’ microbiome – according to initial findings published recently in Communications Biology.

While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy.

An open letter signed by more than 50 industry executives blasts a “fundamentally, fatally flawed” report that urges greater restrictions on the abortion pill.

A bioactive blend of N-trans caffeoyltyramine (NCT) and N-trans feruloyltyramine (NFT) may improve gut barrier integrity in people with diarrhoea-prominent IBD.

Global active consumers want to prioritize better sleep and yet underutilize sleep supplements, according to exclusive Lumina Intelligence data revealed at NutraIngredient’s Active Nutrition Summit. According to insights from Holland & Barrett and industry experts, there is a disconnect between consumer health goals and purchasing behavior, and brands need to find a way to improve effective product communication to bridge the gap.

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products – Rev.16

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertio

Lynozyflic is one of two bispecific antibodies Regeneron hopes will lift its oncology business. Meanwhile, IGM is the latest struggling biotech to agree to a buyout deal from Concentra.

A nitrate-rich isotonic beetroot drink improved time to peak power in sprint interval exercise after five days of supplementation in a new study. The research compared the beetroot isotonic drink to a nitrate-free isotonic control, highlighting benefits of beetroot juice, nitrate supplementation and isotonic drink formats on performance and muscle oxygenation.

Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

Industry veteran Catherine Owen Adams expects external innovation will be key to getting the brain-focused drug developer to “the next level.”

The women’s health focused company acquired the drug for up to $954 million in 2021 through the acquisition of Forendo Pharma.

As an office of the executive branch, the Department of Health and Human Services “does not have the authority” to implement sweeping changes to the structure of the agency as created by Congress, a judge wrote.

Kennedy wants to expand the injury compensation program to include COVID-19 vaccines, while also stretching the “statute of limitations” to more than three years.

The safety update for Vyvgart rattled argenx’s shares on Monday, a reaction that analysts at William Blair said was “overdone.”

California’s life sciences manufacturing jobs dipped 3.7% in 2024, according to a new Biocom California report. Still, several companies made—and continuing making—significant manufacturing investments in the state as key trends shape the discipline.

The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.

Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called bluebird bio? We wanted to know.

Analysts believe that Gilead’s new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say about it.

In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the FDA’s first draft guidance for AI in drug development, published in January 2025, with Archana Hegde, senior director, pv systems and innovations at IQVIA.

CGMP/Finished Pharmaceuticals/Adulterated