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 anti-TL1A antibody from Merck’s 2023 Prometheus buy delivered positive mid-stage results in a skin condition but failed in a certain type of lung disease, the Big Pharma revealed alongside second-quarter earnings.

Lower vaccine demand across every market and more acute pressures in Germany led BioNTech to lower the midpoint of its sales outlook by almost 20%.

This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.

FOR IMMEDIATE RELEASE – July 31, 2026 – Raleigh, North Carolina, Liebel-Flarsheim Company, LLC, is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to the user level (hospitals, imaging center

Publications from Office of Biostatistics Staff

Supernus Pharmaceuticals and Indivior Pharmaceuticals are outlining a combined expected $2.2 billion in annual revenue, plus $125 million in cost savings that will include “natural redundancies.”

BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will take over as CEO in early 2027.

Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway.

If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.

As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.

The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.

Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.

FOR IMMEDIATE RELEASE – July 31, 2026 – Shirley, NY, American Regent, Inc. Animal Health is conducting a nationwide recall of two lots (25011 and 3369) of Adequan® Canine Injection (for dogs), 100 mg/mL 5mL multi-dose vials and two lots (24416 and 25265P) of Adequan® i.m. Injection (for horses), 500

On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic andr

This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.

This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.

After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior motive” and “biased intentions.”

The investment will expand Resilience’s U.S. capacity to make the KwikPen device Eli Lilly uses to deliver its injectable diabetes and obesity medicines.

AbbVie investors’ sky-high expectations led to a 4% share decline on Friday as the company reported more modest consensus beats than expected.

Novo Nordisk’s IL-6 inhibitor ziltivekimab failed to reduce the risk of cardiovascular events in the late-stage trial, dashing hopes for an edge in the hyper-competitive cardiometabolic space.

Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.

Alnylam’s revenue cut “may create a near term credibility overhang and could “raise questions on peak sales potential, even if there’s tailwinds in the competitive landscape,” according to Stifel.

UniQure is ready to put its Huntington’s disease gene therapy through an advisory committee meeting—even as the broader rare disease space has been put on edge by recent FDA scrutiny of assets by Replimune and Capricor.

Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death.

The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but trial design was a major sticking point as the panel deliberated.

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Strong quarterly results are prompting Bristol Myers Squibb to lift its 2026 outlook, though the company is facing another delay for key Cobenfy Alzheimer’s data and a pushed-back readout for milvexian.

Calls for Regeneron to step up dealmaking have intensified as the company has established an $18 billion cash pile and suffered clinical trial setbacks.

With Enhertu and Datroway hitting their peak revenue and rivals flowing into the antibody-drug conjugate space, Jefferies cuts expectations for Daiichi Sankyo.