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…

Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts.

The development saga for the depression molecule has been rocky for years, unable to ease symptoms in multiple late-stage trials.

The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech noting that the regulator found its neurodevelopmental findings for the gene therapy to be “robust.”

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

This page contains the Gastrointestinal roster, which lists the current members and the current number of vacancies for the committee.

Psychopharmacologic Drugs Advisory Committee Roster

CDER’s Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.

Current operations chief Renee Gala will succeed Bruce Cozadd at Jazz. Meanwhile, a key study of an Ultragenyx and Mereo drug is continuing past a second interim analysis.

The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary patents will need to hold up.

Ostia Sciences Inc. and EXPERT’Biome recently announced a new oral care probiotic through Contract Development and Manufacturing Organization Lallemand to launch clinical trials. The collaboration sets the stage for an oral probiotic launch which will introduce beneficial bacteria to combat gingivitis, highlighting a shift towards preventive oral care.

NPA’s Fly-In Day showcased nearly 90 years of advocacy, emphasizing relationship-building over lobbying. Members engaged with U.S. lawmakers on issues like modernizing drug preclusion clauses, expanding dietary supplement access, and reducing dependence on China.

Following a 25-year career as a sports dietitian, Renee McGregor provides key insights into the unique nutritional needs of the female athlete.

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the agency during deramiocel’s review.

In its complete response letter, the FDA cited insufficient evidence establish deramiocel’s effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER Director Vinay Prasad canceled an advisory committee meeting for the therapy.

The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli Lilly’s Alzheimer’s antibody Kisunla, Sarepta’s DMD gene therapy Vyondys 53 and Gilead’s HIV drug Sunlenca.

Vaccine to be used only when there is a significant chikungunya risk and after careful consideration of the benefits and risks EMA’s safety committee (PRAC) has completed its…, Agenda Agenda of the PRAC meeting 7-10 July 2025DraftReference Number: EMA/PRAC/202278/2025 English (EN…, PRAC statistics: July 2025 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Preliminary quarterly sales figures for Vykat surpassed Wall Street estimates, but shares fell on concerns the company may not be courting a buyer.

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public insight into the reasons new drug and biologics applications got rejected.

In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines, and Pad Chivukula of Arcturus Therapeutics.

The deal, which involves a $700 million upfront payment, gives AbbVie access to ISB 2001, a clinical-stage first-in-class trispecific antibody currently being tested for certain kinds of multiple myeloma as well as autoimmune indications.

Partners Ultragenyx and Mereo BioPharma saw their stocks drop by 21% and 30%, respectively, after announcing that the Phase II/III study of their osteogenesis imperfecta candidate will proceed to final analysis, implying it did not show sufficiently strong results at an interim analysis.

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.

The move has sparked concern that the U.S. Preventive Services Task Force could soon be dismissed after a decision by the high court affirmed Health Secretary Robert F. Kennedy Jr.’s power to remove its members at will.

The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.

The number of employees laid off and companies letting people go increased year over year during the first half of 2025. BioSpace recaps the five largest layoff rounds, including cuts at Bayer, BMS and Teva.

The biotech is taking inspiration from cystic fibrosis treatment and applying a similar approach to developing "corrector" and "potentiator" medicines for the kidney disease.

Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer.

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.