The physIQ monitoring platform will be used to evaluate an inhaled treatment, developed by InCarda, that is intended to treat atrial fibrillation patients.
With updates to the Guideline for Good Clinical Practice Advancements on the horizon, an industry expert offers some perspective on what might be ahead.
The Foundation for Sarcoidosis Research hosted more than 50 agency leaders in a session that addressed patient concerns in research, care, and diagnosis.
The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.
If new restrictions are placed on the FDA’s Accelerated Approval pathway, as many as two thirds of the treatments that use this pathway would never reach patients, according to research released at the BIO International Convention last week.
This year’s DIA Global Annual Meeting (taking place June 19-23 in Chicago) reunites professionals for face-to-face learning and networking opportunities.
Efanesoctocog alfa is an investigational factor III therapy designed to prevent bleeds and bleeding episodes in patients diagnosed with the rare disorder.
The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.
The agency has removed the hold placed on the pharmaceutical company’s IND for injectable lenacapavir, which is intended for HIV treatment and prevention.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.
An expert from the organization discusses ahead of his CPhI North America presentation how tomorrow’s drugs can’t all be formulated with yesterday’s excipients.
An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.
The US Food and Drug Administration has approved a move to make the oral lead-in period for ViiV Healthcare’s once-every-other-month drug Cabenuva optional.
An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.
A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.
The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.
The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.
The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
The pharma company is evaluating its Paxlovid oral treatment, intended for high-risk patients who have tested positive for the virus, in pediatric subjects.
A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.
The agency has given the go-ahead for a Phase I study of the company’s IO-202 antibody (in combination with Merck’s Keytruda) to treat various tumor types.
The CRO is helping out on a project exploring the effects of the virus in children; other members of the research team include experts from Duke University.
According to a representative from the decentralized trial solutions company, the field of digital therapeutics is poised to gain significant popularity.
The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.
The pharma firm has announced the agency has approved the company’s investigational new drug application for its Phase II trial of pemvidutide for obesity.
A representative from IQVIA discusses the particulars of the US agency’s new draft document and shares what it might mean for clinical trial data evaluation.
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.
Blue Note Therapeutics has announced the status has been granted to BNT200, a device to treat anxiety and depression in acute myeloid leukemia patients.
This month’s news on mergers and acquisitions, hires, and other developments includes notable firms like Altasciences, Protocol First, WuXi STA, and more.
It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.
OSP’s list of the year’s most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.
The pharmaceutical company has announced GMP-related challenges with a manufacturer contracted to fill syringes for Wegovy pens headed to the US market.
The US agency continues to work with industry professionals on vaccines and treatments for the virus, and to wrestle with current and emerging variants.
The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.
A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.
The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.
The HIV treatment specialist has sent an application to the agency for tolutegravir, a single-tablet treatment indicated for children living with the virus.
As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.
Stakeholders in the Rare Disease Cures Accelerator-Data and Analytics Platform initiative are partnering in hopes of bringing treatments to patients faster.
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.
The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.
The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.
Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.
