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…

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.

To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint

Follow along as BioSpace tracks job cuts and restructuring initiatives.

I-Mab is rebranding as a company that will form individual drugmaking subsidiaries. Elsewhere, Sanofi cut an immune drug deal and investors poured $140 million into a new hair loss treatment.

CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker.

Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer.

A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine were among the first beneficiaries of a pilot program initiated in June. 

The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.

With more than $1.5 billion on the line, Gilead looks to bolster its CAR T portfolio.

EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza.

EMA has recommended granting a marketing authorisation in the European Union (EU) for Brinsupri (brensocatib) 25 mg tablets, for the treatment of non-cystic fibrosis…

During this webinar BioSpace sits down with former FDA Chief Information Officer Vid Desai to discuss the potential advantages and pitfalls of deregulation stemming from one of President Donald Trump’s first executive orders. Together, they uncover what this shift means for drugmakers, compliance and patient safety.

Shares of Praxis Precision Medicines more than tripled Thursday, peaking at $200 apiece, after the company disclosed positive data from a pair of late-stage clinical trials.

In this episode presented by PII, BioSpace’s head of insights discusses decentralized clinical studies and how connected technology can improve patient compliance with guests Oliver Eden and Travis Webb.