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…

The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.

After a strong open to the year, the public markets suffered a six-month drought that led to biotech’s tightest IPO window in years.

AI is reshaping pharma faster than any tech wave before. Learn where to start and how to scale.

The U.S. Food and Drug Administration approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

The company submitted an application for a seasonal flu vaccine it believes to be a key growth driver in the years ahead. 

The fierce rivalry between Novo Nordisk and Eli Lilly is alive and well, as the two companies are expected to face off with their new obesity pills this year.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

After getting the crucial first-mover advantage with an FDA approval for a weight loss pill, Novo Nordisk looks to win the market before rival Lilly can arrive with its own oral option for obesity.

After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.

One way Takeda lives out its values is by striving to ensure that patients are aware of and can access the company’s clinical trials. Two employees from its research and development organization discuss why representation matters and the work their team is doing to benefit patients now and in the future.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

While Novartis secured the biggest deal of the fourth quarter, a handful of riveting tales emerged from the bottom of the M&A list, including a zombie buyout and a bidding war. And no, we’re not talking about Metsera.

The major depressive disorder failure for BHV-7000 is the drug’s second, after Biohaven’s spinocerebellar ataxia treatment troriluzole was rejected by the FDA in November 2025.

With a pair of Phase III trial flops, Ultragenyx will explore cost reductions as analysts turn attention to an upcoming Angelman syndrome readout.

July – September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Discover potential signals of serious risks and new safety information identified by the FDA’s Adverse Event Reporting System (FAERS). Learn how the FDA monitors and evaluates drugs for safety concerns, providing important updates on adverse events to protect public health.

More than a dozen pharmas have recently struck deals with the White House to lower drug prices. Nevertheless, drugmakers reportedly plan to raise the U.S. prices of at least 350 branded medications.

Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.

Both companies received agency requests for more evidence of the effectiveness of their therapies.

Four of this year’s biggest acquisitions topped 11-figure figures. One was 2025’s messiest bidding war.

Despite the definitive failure of Novo Nordisk’s semaglutide in Alzheimer’s, biotech executives, analysts and other industry experts see potential in more testing of GLP-1s for the neurodegenerative disease, particularly in a combination approach.

Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions. 

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program (CDRP)

CDER – Biological Product Deviations