A US federal judge ruling that a Californian clinic’s stromal vascular stem cell treatments do not fall under the FDA's regulatory jurisdiction is of significant concern, says the ISCT.
The US regulator has granted emergency authorization for Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant.
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
Pfizer and BioNTech have completed their application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine: saying they stand ready to start shipping...
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
Bavarian Nordic A/S has received approvals from the US and EU regulatory authorities to manufacture its Jynneos/Imvanex smallpox and monkeypox vaccine at its fill and finish facility in Denmark.
Sandoz said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a natalizumab biosimilar, developed by Polpharma Biologics.
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.
A meeting of the FDA’s vaccines and related biological products advisory committee (VRBPAC) voted Tuesday to recommend that the agency grant Emergency Use Authorization (EUA) for Novavax’ COVID-19 vaccine.
The US Food and Drug Administration (FDA) has approved GSK’s Priorix (Measles, Mumps and Rubella Vaccine, Live) for individuals 12 months of age and older.
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The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
In a simulation model, lecanemab treatment was estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to early AD.
The FDA has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older who cannot access other approved COVID-19 shots for various reasons.
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 diagnostics and drug development company, Labcorp, is partnering with San Francisco based, Xcell Biosciences, to advance efforts to help clients bring cell and gene therapies to market.
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
The International Society for Cell & Gene Therapy (ISCT) has established a task force to ensure that the CGT field advances in an ethical manner and that the expanded access route is being used for its intended purpose.
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
There is a healthy appetite for continued investment in gene therapy, in new modalities and more indications, says an industry insider as he reflected on the prospects for the US gene therapy sector next year.
The US Food and Drug Administration (FDA) has amended the emergency use authorizations (EUA) for Pfizer/BioNTech and Moderna COVID-19 vaccines: authorizing the use of a booster shot for all individuals aged 18+.
The US Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include a single booster dose in certain populations.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTech’s COVID-19 vaccine Biologics License Application (BLA).
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
Statisticians at the US Food and Drug Administration (FDA) said there was insufficient evidence to support the agency’s approval of the Alzheimer’s drug produced by Biogen, according to newly released internal memos.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.
The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.
June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital – featuring Dr. Anthony Fauci, Director of NIAID at the NIH – will focus on four decades of innovation as well as the critical...
Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.
Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.
The Pfizer/BioNTech COVID-19 vaccine – which requires ultra-cold storage – will now be allowed to be transported and stored at standard freezer temperatures for up to two weeks in the US.
The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use...
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
US President Biden’s team is using the US Defense Production Act (DPA) to launch a full scale “wartime effort” to address the supply chain shortages inherited from the Trump administration.
