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…

A trifecta of newly inked tech partnerships—from Eli Lilly, Bristol Myers Squibb and Incyte—exemplify the increasingly central role that AI is playing in drug development.

After being hit by safety issues and subpar results in another trial, BioMarin’s Phase 3 test of Voxzogo for a rare skeletal disorder called hypochondroplasia showed efficacy “solidly above” what the drug has shown for achondroplasia, which causes dwarfism.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They explore Germany’s biotech and life sciences ecosystem, including the science, infrastructure and policy changes needed to help European companies scale globally while staying rooted in Europe.

The number of biotech and pharma professionals taking jobs they’re overqualified for is now over 50%, based on a BioSpace LinkedIn poll. A recruiting firm executive discusses the trend, the reasons behind it and why it doesn’t have to derail careers.

Certain labels used with i.v.STATION automated compounding systems may not be detected, leading to mislabeled sterile filled syringes.

A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.

React Health is removing affected devices due to a manufacturing process deviation that may result in an undetected oxygen leak condition.

Eli Lilly joins hands with Engage Bio, acquiring the DNA delivery platform developer in hopes of bolstering its genetic medicines portfolio.

While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”

FDA veteran Richard Pazdur outlined his priorities for the next FDA commissioner but stopped short of putting himself forward as a candidate to lead the agency at an RBC Capital Markets event on Tuesday.

While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.

While both Beam Therapeutics and Wave Life Sciences touted notable biomarker benefits for their respective alpha-1 antitrypsin deficiency assets, analysts said that Beam might have the efficacy advantage as Wave’s drug hits an efficacy “ceiling.”

Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.

BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.

Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.

Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.

Far fewer companies are letting employees go so far in 2026 compared to 2025, but the number of people affected is trending up, especially this month, according to BioSpace tallies.

Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.

Who reviews medical error reports for human drugs? Meet FDA’s Division of Medication Error Prevention and Analysis. According to the National Coordinating Council for Medication Error Reporting and Prevention, “a medication error is any preventable event that may cause or lead to inappropriate medic

BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.

A month after reporting that its RAS inhibitor daraxonrasib doubled survival in advanced pancreatic cancer, Truist said Revolution Medicines “is evolving into a major revenue-generating oncology company,” and projects an approval in second-line disease by the end of the third quarter.

Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline.

Baxfendy, the first aldosterone synthase inhibitor to be approved by the FDA for high blood pressure, is among the products AstraZeneca is relying on to hit its 2030 goal of $80 billion in revenue.

The FDA has previously linked eight deaths in the U.S. to Tavneos and has alleged that doctored data were used to support the drug application that led to its approval in 2021.

On May 15, 2026, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of adults with HER2-positive (I

As is standard practice, the FDA is notifying consumers not to use expired Amazon Basic Care Levonorgestrel 1.5 mg.

Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint

California life sciences jobs declined 1.8% last year, according to the new California Life Sciences sector report. While National Institutes of Health funding and venture capital investment rose, their growth slowed from the previous year.