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…

Armed with the latest biological knowledge and cutting-edge computational techniques—and, of course, investor dollars—these six biotechs are playing in the largely underappreciated longevity space, developing therapies that may improve the quality of aging.

AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.

Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.

Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

While Trump indicated drug levies would be set at a “very high” rate, he added that pharma firms would first be given time to bring manufacturing back to the U.S.

Cypress and Cepham on supporting Wings of Hope

BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose BLA was withdrawn in 2023. A Phase IIIb trial was scheduled to begin last month.

The researchers uncovered that a complex microbial ecosystem consisting of 115 previously unreported bacterial genomes exists among the Yanomami, a group living in regions of Venezuela and Brazil.

The deal marks an end for CAR T company Cargo Therapeutics, which has been slashing its workforce and cutting programs since the January decision to halt its lead candidate for a certain type of aggressive large B cell lymphoma.

CGMP/Finished Pharmaceuticals/Adulterated

Global Harmonization Working Party (GHWP) has voluntarily withdrawn from IMDRF.

A readout from the company’s SUMMIT trial put its small molecule bezuclastinib on a collision course with rival Blueprint’s Ayvakit, which Leerink analysts said does not sufficiently treat all patients.

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an on-time approval.

Soundbites recently secured a patent for its nutraceutical formulation, known as ACEMg, which is designed to ‘preserve or restore hearing’ in individuals with hearing loss unrelated to viral infection.

The partnership will give Chugai access to Gero’s artificial intelligence technology to discover novel targets in aging-related diseases. Chugai will then develop antibody-based drugs based on the findings.

Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Verify licensing through FDA database links.

After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies.

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due to resource constraints and reports surfaced that Commissioner Marty Makary tried to have the application rejected.

In the United States, only 31.4 % of phase II/III clinical trials in oncology are successfully completed1. The causes of this dramatic economic and time-consuming loss are, among others, protocol design and patient recruitment challenges.

Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of its former self under Health Secretary Robert F. Kennedy Jr.

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.