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…

EY’s 2025 Biotech Beyond Borders report provides a sobering snapshot of the industry’s financial health, with more and more companies facing cash runways of less than one year. The analyst firm’s leaders urge a return to basics for biotech.

Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.

The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.

Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.

The new version of the bill will still need to go through the entire House and Senate.

Andembry is the first monthly Factor XIIa inhibitor for the prevention of HAE attacks and will be available to patients “before the end of June,” CSL announced.

Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.

Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug developers from targeting the U.S. market, potentially benefiting domestic producers of biosimilars.

The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.

The deal centers around a medicine that could “shift the treatment paradigm for cardiovascular disease,” Lilly said, but also follows a yearslong decline in Verve’s share price amid skepticism over the need for such a therapy. 

Participants using Liquid I.V. exhibited extended hydration duration by retaining fluids for up to four hours, longer than those who drank water alone, says a new study.

Nearly $30 million in tax incentive awards are expected to add 1,519 new life sciences jobs in Massachusetts, with about 52% of the positions spread over Boston and Cambridge. Vertex, which received the largest award, will create hundreds of roles in Boston.

Jefferies analysts said on Tuesday that Ventyx could leverage its mid-stage data for VTX3232 to position the oral drug candidate as a treatment for other neurodegenerative diseases, including Alzheimer’s.

The pending deal was rumored overnight after a report from the Financial Times, spurring analysts to speculate that if true, the entire gene editing space would see a boost at the markets.

The Hippo 072 Aspiration System is used to remove stroke-causing clots but there may be issues with the distal tip during clot removal.

Blood Products Administration Sets recalled due to incorrect assembly. Use may lead to administration of unfiltered blood or delays in therapy.

Medline Neonatal and Pediatric convenience kits that include Smiths Medical ORAL/NASAL Endotracheal Tubes are used for intubation.

The deal gets NextCure the rights to Simcere’s novel ADC for solid tumors outside of China.

Attorneys said many questions remain about test regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

Emerging evidence suggests that targeting the maternal gut microbiome during pregnancy could be critical for both mother and baby.

At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.

As GLP-1 weight loss drugs become more common, managing side effects has emerged as key to adherence. A Kerry Group consumer perception study suggests its BC30 Probiotic may help reduce digestive discomfort linked to these medications.

Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.

The 2025 BIO International Convention (BIO2025), the world’s largest annual biotech event, will take place from June 16 to 19 (U.S. time) at the Boston Convention & Exhibition Center. This year, Taipei City Government is partnering with six Taipei-based biotech companies, including PanCAD.ai Co., Ltd., Instant NanoBiosensors Co., Ltd., Bened Biomedical Co., Ltd., Cancer Free Biotech Ltd., Xantho Biotechnology Co., Ltd., and Energenesis Biomedical Co., Ltd., to showcase their innovations at the Taiwan Pavilion (Booth #1645) in the Taipei Exhibition Area.

AstraZeneca, Pfizer and more are leveraging the computational power of AI to better design trials, predict the potential efficacy and safety profiles of their molecules and synthesize massive multi-omic information to gain a more complete understanding of challenging cancers.

Infusion pumps released with incorrect software can experience unexpected performance problems, including issues with essential functions and risk measures.

This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee.

Office of New Drugs Custom Medical Queries (OCMQs) are standardized groupings of similar adverse event terms intended to assist with the identification of potential safety issues during review of adverse event data.

The Standard Safety Tables and Figures (ST&Fs) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the safety review of products across Divisions.