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…

While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.

Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.

Daiichi Sankyo’s full-year report was originally scheduled for April 27 but has now been pushed back to May 11. That same day, the pharma expects to release its five-year business plan.

Pfizer’s decision to cut its early-stage cancer asset was due to “strategic business reasons” and not driven by safety or efficacy concerns.

Of the 17 companies that were implored by the White House last July to apply Most Favored Nation pricing to their drugs, Regeneron is the last to agree—the same day the FDA greenlit its gene therapy for hearing loss in kids.

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

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

Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers

Digital Health Technologies (DHTs) for Drug Development

List of Active RDRC Sites

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.

The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.

Chief Scientific Officer Pedro Beltran will succeed Eli Wallace as CEO of BridgeBio Oncology Therapeutics, as the board eyes a busy period of clinical advancement in the RAS oncology space.

Sanofi’s interim leadership sought on a Thursday earnings call to quell concerns that its sudden defense of Dupixent’s patents had anything to do with the departure of CEO Paul Hudson.

Roche and Zealand Pharma announced last month that their amylin analog petrelintide elicited a 9% placebo-controlled weight reduction at 42 weeks—falling far below analyst and investor expectations.

The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.

This year’s American Academy of Neurology meeting included a presentation that could one day set a new treatment standard for myasthenia gravis.

The Durham plant will manufacture immunology, neuroscience and oncology drugs once AbbVie finishes construction in 2028.

In this episode of Denatured, you’ll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.

Looking for a biopharma job in Illinois? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.

While life sciences employment was down 0.3% nationally in 2024, it rose 1.9% in Washington, according to a new Life Science Washington report. The association’s CEO discusses the latest findings and how the state’s job market looks this year.

Women and nonwhite racial/ethnic groups are still earning less in the life sciences. An industry consultant discusses the pay disparities, ways to fix the gaps and why change is needed.

Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.

New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.