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…

Fosfomycin Injection

Despite showing no meaningful benefit on lung function, Arcturus’ mRNA therapy ARCT-032 reduced mucus volume in patients with cystic fibrosis—an outcome William Blair found “potentially promising.”

With Avadel under its fold, Alkermes expects to accelerate its expansion into the sleep market, laying the foundation for its late-stage narcolepsy asset alixorexton.

A key question for investors going forward will be whether Moderna’s other latent virus vaccines for Epstein-Barr and shingles can succeed after the failure of the CMV program.

Biopharma professionals have become increasingly likely to be dishonest when interviewing for jobs, based on BioSpace interviews with three talent acquisition experts. The experts discuss the reasons why as well as the types of fraud happening, including people posing as applicants.

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

A shot analysts projected as a multibillion-dollar seller produced results “well below” the company’s expectations, heightening pressure on Moderna’s flagging respiratory vaccine business.

Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations.

Analysts called the proposed purchase of Avadel Pharmaceuticals a “clear” strategic fit for Alkermes, handing it an already marketed product for excessive daytime sleepiness.

The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in infectious disease and other oncology indications.

While the threat of tariffs dies down for the pharma industry, President Donald Trump is reportedly weighing a new investigation that could result in import taxes against U.S. trading partners that don’t pay enough for drugs.

Seven in 10 U.S. hiring managers say their company usually considers employing overqualified applicants, according to a survey from Express Employment Professionals and The Harris Poll. However, 75% of employers believe such hires struggle to stay motivated in lower-level roles.

The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that until recently accounted for 20% of innovative medicine sales.

Seven Novo Nordisk board members have resigned. The new board headed by former Novo Nordisk CEO Lars Rebien Sørensen will align behind the new CEO’s massive restructuring plan.

The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.

The biotechs will assess a combination of two drugs against HER2-positive breast cancer. Elsewhere, Merck unveiled the latest piece of its more than $70 billion domestic manufacturing investment.

The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.

EMA has launched its first social media campaign working with content creators. The #HealthNotHype campaign aims to raise awareness about the safe and responsible use of GLP-1…, “#HealthNotHype is about passing the message that GLP-1 receptor agonists are not magic solutions for weight loss. Like all medicines, they have benefits and risks and…, Partnering with content creatorsThe Agency carefully selected content creators from seven different Member States of the European Union (EU) to ensure a balanced geographical…, CountryChannelFollowers (on 16 October 2025)Finlandjennipuolivali39,000Germanymedicinexcare242,000Italyinfermieregianluca175,000Latviauzlabo32,800…

To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.

The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.

Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.

Ivonescimab’s progression-free survival data in non-small cell lung cancer bode well for an upcoming overall survival readout, according to Truist analysts, who noted that “OS is likely to be statistically significant” in favor of the PD-1/VEGF bispecific.

GenAI is changing how pharma teams work — making data accessible, transparent, and actionable.

Recent headlines proclaim a ‘potential’ or ‘functional’ cure for multiple myeloma, but the fight against the disease must continue.

After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain.

Results presented at the European Society for Medical Oncology meeting could help separate Roche’s medicine from similar hormone-degrading drugs for breast tumors.

The Food and Drug Administration is advising consumers not to purchase or use Ashfiat Alharamain Energy Support, a product promoted and sold for male sexual enhancement on various websites, including Amazon.com (Akkarco, LLC storefront), and possibly in some retail stores.

The Food and Drug Administration is advising consumers not to purchase or use Black Thai Honey, a product promoted and sold for male sexual enhancement on various websites, including www.honeypacks.com, and possibly in some retail stores.