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…

Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.

Clinical Investigator

In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with ⁠Ana Pedro Jesuíno⁠, global head local QPPV network at IQVIA.

In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO Vas Narasimhan told reporters that for most medicines, it typically takes three to four years to completely relocate production.

In the first six months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under 130 staff during the same period last year.

FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.

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

1 in 5 respondents either have had or do have a fractional role, according to a recent BioSpace poll, and over half are considering it. Two recruitment experts, a fractional worker and an aspiring fractional worker share their insights.

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

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.

Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used.

Dexcom recalls certain receivers that may fail to sound alerts. Missed alerts could delay detection of severe blood sugar events, causing seizures or death.

Johnson & Johnson’s $23.7 billion in second-quarter earnings, driven by cancer and neuroscience drugs, exceeded analyst expectations, while CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030.

Stradling Law partner Shawn Collins outlines legal best practices for cosmetics manufacturers navigating evolving consumer protection litigation.

In advance of this week’s adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival.

Drawing from her mother’s natural health background and her own experience, Caitlyn Vanderhaeghe, president and CEO of Kidstar Nutrients, identified a crucial gap in the market for quality children’s supplements.

NEW YORK – June 26, 2025 – PRLog — In a bold fusion of evolutionary biology, aerospace engineering, and comparative physiology, Dr. Vlad Reznikov, MD, PhD, MBA, today unveils “Thought Experiment: Extrapolation of the Reverse Bionic Mechanisms in the Reconstruction of the Anatomy and Biology of a Hypothetical Dragon”. The monograph is the first academically formatted attempt to reverse-engineer the legendary dragon…

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Workshop record available fthrough GRRP Working Group

Pfizer’s sudden market withdrawal of sickle cell therapy Oxbryta, which some analysts predicted would reach $750 million in sales by the end of the decade, has left patients and healthcare providers with few options, while investors question the pharma giant’s dealmaking prowess.

EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a…, Related contentCommittee for Medicinal Products for Human Use (CHMP)Referral procedures: human medicines

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

In today’s digital age, having a strong online presence is critical for companies in the regulatory compliance industry. Pattern of USA Inc., a leader in Regulatory Affairs consulting, has successfully boosted its online visibility and ranking through platforms like Active Search Results, a powerful search engine optimization tool that helps businesses achieve higher search rankings….

Before companies and investors look towards the future, they must first understand the opportunities and challenges AI presents to them. From the benefits included in advancing processes to cybersecurity hazards, AI innovation is a balanced scale of oppportunities and risks.

With an FDA action date of Sept. 26, Bristol Myers Squibb’s KarXT could soon be the first new type of schizophrenia drug in three decades—and the company also sees potential in Alzheimer’s psychosis and bipolar disorder.

Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

MEGA SOFT and MEGA 2000 Patient Return Electrodes used during monopolar electrosurgery may cause serious patient burn injuries.

Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation.

The European Commission has issued its decision on the Imvanex extension of indication in adolescents on 19 September 2024., EMA has recommended extending the indication of the smallpox and mpox vaccine Imvanex to adolescents from 12 to 17 years of age.Imvanex is already authorised in the European Union…