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…

In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input.

Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.The committee recommended granting…, Positive recommendations on new medicines , Aucatzyl International non-proprietary name (INN) obecabtagene autoleucel…, Blenrep INN belantamab mafodotin  Marketing-authorisation applicant…, Ezmekly INN mirdametinib Marketing-authorisation applicant…, Itovebi INN inavolisib Marketing-authorisation applicant…, Maapliv INN amino acids Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Bomyntra INN denosumab  Marketing-authorisation applicant…, Conexxence INN denosumab Marketing-authorisation applicant…, Rolcya INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Riulvy INN tegomil fumarate  Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Emtricitabine/Tenofovir alafenamide Viatris INN emtricitabine / tenofovir alafenamide…, Withdrawal of initial marketing authorisation application , Teriparatide Ascend INN teriparatide Marketing-authorisation applicant…, Negative opinion of initial marketing authorisation application , Atropine sulfate FGK INN atropine Marketing-authorisation applicant…, Kinselby INN resminostat mesilate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Imfinzi INN durvalumab Marketing-authorisation holder…, Rezolsta INN darunavir / cobicistat  Marketing-authorisation holder…, Saxenda INN liraglutide Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Withdrawal of extension of indication , Lutathera INN lutetium Marketing-authorisation applicant…, Re-examination of recommendations , Aplidin INN plitidepsin  More information…, Winlevi INN clascoterone More information Winlevi…, Start of referral procedure , Ipidacrine INN ipidacrine More information EMA…, Outcome of referral procedure , Azithromycin containing medicinal products for systemic use INN various More…, Other updates , Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025AdoptedReference Number: EMA/170235/2025 English (EN…

Analysts were effusive about Merus’ new HNSCC data, writing that petosemtamab could “become the standard of care” in the first-line setting for this indication.

EudraVigilance registration manual

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.

The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.”

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

EMA’s human medicines committee (CHMP) has started a review of medicines containing ipidacrine. These medicines have been authorised in several EU countries through national…

The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been r

Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen

The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their booster doses to the “JN.1” coronavirus lineage.

Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.

Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung cancer, according to one physician.

Already a Vigil Neuroscience investor, Sanofi has agreed to buy the rest of the biotech’s shares for $8 apiece, representing a total deal value of $470 million.

Speaker Mike Johnson negotiated a number of last minute changes to the megabill to get it across the finish line, including moving up the start date for Medicaid work requirements. 

The Danish drugmaker unveiled a series of initiatives to increase access to Wegovy and clamp down on use of the knock-off versions that have dented its sales forecasts.

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

A BioSpace survey found that 56% of employed and 81% of unemployed respondents are considering jobs outside biopharma. Some are also seriously thinking about leaving the U.S. to find employment in the field.

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

In April, Kingswood Capital Management and Performance Investment Partners announced an agreement through which an affiliate will acquire The Vitamin Shoppe from the Franchise Group. This week, the acquisition was completed, and a familiar face was named CEO.

Targeted nutritional strategies may help improve sleep, with emerging science suggesting that supplements such as probiotics, creatine, botanical extracts and micronutrients can improve sleep quality, duration, and efficiency. Here’s a look at some of the more recent studies investigating how supplements may contribute to a better night’s sleep.

The retailer credits loyalty programs, product standards and private-label growth for sustained momentum and a net sales increase of 9.0% to $335.8 million in Q2 FY2025 compared to Q2 FY2024.

In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.

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

Nine states in the Southeast showed growth in bioscience employment and establishments from 2019 to 2023, according to 2024 data from BIO and TEConomy Partners. NCBiotech and Bexion executives discuss the area and the pros and cons of setting up shop far from major hubs.

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.

Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.”

Honey contains a rich nutritional profile of sugars, proteins, enzymes, vitamins, minerals, amino acids and polyphenols. Some honeys have richer nutritional profiles than others.