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…

Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year.

The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.

Excellergy is developing medicines that combat allergic responses in three different ways, a multipronged effect the company says could lead to faster and more complete disease control.

Moderna’s mRNA-4359, when used with Keytruda, achieves a 24% overall objective response rate in patients with melanoma, with efficacy increasing to 67% in those positive for PD-L1.

Unlock value with optimized workflows and scalable technologies.

While the benefits of AI are clear, the amount data sets needed for effective AI integration is proving to be a challenge. This is particularly true for cell therapy companies as they are eagerly seeking ways to reduce development costs. Two experts at Charles River Laboratories provide insights by giving their takeaways from their own AI integrations.

The market outlook is full of uncertainty and pitfalls. Experts weigh in on how to mitigate risks.

Study results published in The New England Journal of Medicine show the therapy significantly improved hearing in nearly a dozen children with a rare, genetic form of deafness.

“HHS employees across multiple divisions have received reduction-in-force notices,” an administration spokesperson confirmed. It’s a significant escalation of normal shutdown procedures.

The British pharmaceutical giant has joined the direct-to-consumer push, following Pfizer and Amgen’s announcements in response to the president’s calls to lower U.S. drug prices.

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco

Information related to FDA’s preparation for the fourth reauthorization of GDUFA will be hosted on this page as it becomes available.

FDA Drug Alerts and Statements

The acquisition of the well-funded startup is the fourth this year involving companies with technologies that can genetically modify immune cells inside the body. 

A new version of the controversial bill removes the specific company names that were included in a previous iteration but still requires the industry to ditch Chinese biotech contractors in order to receive federal dollars.

Investor reaction to the deal was muted, with BMO Capital Markets analysts saying they “continue to look for more” from Bristol Myers Squibb before they can “get excited about the near term turnaround story.”

The British pharma is adding $500 million, and ADC production capabilities, to a planned Virginia facility. Elsewhere, Ferring announced layoffs and Sanofi touted a radiopharmaceutical drug.

AviadoBio will have the option to exclusively license UGX-202, a vision-restoring gene therapy for the rare eye condition retinitis pigmentosa.

Bevi, the company behind Smart Water Coolers just launched Focus Blend, a functional enhancement that combines caffeine, L-theanine, magnesium and B vitamins for sharper focus. The offering was inspired by the growing focus crisis.

MartinBauer has acquired American Botanicals, a Missouri-based company known for its wildcrafted herbs and commitment to sustainable practices. This acquisition strengthens MartinBauer’s ties to U.S. agriculture and provides American Botanicals access to MartinBauer’s processing, R&D and quality standards. Both companies aim to leverage their strengths to secure supply, drive innovation and expand market access while preserving their heritage and ensuring continuity for growers and customers.

GoodRx, an online platform that offers drug discount coupons to patients, is in talks with the government to participate in the forthcoming TrumpRx program.

The British proposal to increase support for pharma is “clearly positive,” according to analysts at Leerink, who noted that the NHS’ move will improve patient access to treatments.

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Zoetis Belgium for Lenivia…

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

Taking place Oct. 27 to 30 at Mandalay Bay Convention Center in Las Vegas, SupplySide Global 2025 will host over 1,600 ingredient suppliers, contract manufacturers, flavor houses and solution providers who are ready to connect. Here’s a sneak—but not exhaustive—peek at what to expect in the supplement and adjacent aisles of the show floor this year.

Outside the bustle of the exhibition halls, SupplySide Global hosts a full program of education sessions for those wanting a deeper look at the shifting regulatory and market forces shaping the future of the supplement space.

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access

Novo will add Akero’s efruxifermin to its MASH portfolio, which includes Wegovy after the GLP-1 gained an FDA nod in the indication earlier this year.

The CDC’s Advisory Committee on Immunization Practices was scheduled to convene Oct. 22 to 23, but this meeting has been postponed, with no new date specified. The delay comes as the VA published new research showing that COVID-19 shots prevented hospitalizations and death.