Tag: FDA

January 16, 2024

CellVoyant—an artificial intelligence (AI) first biotechnology company spun out of the University of Bristol—has raised £7.6 million in seed funding to speed up the development of novel cell therapies. According to a Jan. 16, 2024 press release, the funding was […]

January 12, 2024

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and […]

January 11, 2024

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the […]

January 9, 2024

The deal – announced at the JP Morgan Healthcare conference this week – includes a sizeable $1 billion upfront payment, with up to $400 million more on the table if Aiolos’ pipeline delivers the results GSK is hoping for. AIO-001 […]

January 9, 2024

Prescription drug pricing has been an ongoing issue in the US, which is reportedly spending more than double the average amount spent by other OECD member countries on prescription medicines per capita. Florida’s Canadian Prescription Drug Importation Program, which will […]

January 8, 2024

Applesauce fruit puree pouches under recall and investigation for toxic lead levels may also contain another toxin, chromium, according to an update released Friday by the U.S. Food and Drug Administration (FDA). The products under recall are WanaBana, Weis and […]

January 4, 2024

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]

January 3, 2024

Goldman’s foray into the biotech world shows continuing investor appetite in the venture capital arena, even while the public biotech market remains tepid. The last year featured a number of new VC fund launches, including from Dimension, Cure Ventures, Yosemite, […]

January 2, 2024

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and […]

December 29, 2023

Researchers appear to have discovered a new weapon in the war on a particularly difficult foe. They have identified a previously unrecognized class of antibodies that seem to be capable of neutralizing multiple strains of the flu virus. Their findings, […]

December 22, 2023

The US approval is the first in the world for Wainua (eplontersen), a once-monthly antisense treatment that can be self-administered by subcutaneous injection. According to AZ and Ionis, it is the only drug for ATTR polyneuropathy that doesn’t need to […]

December 21, 2023

The latest complete response letter (CRL) for gefapixant comes even though the drug is already on the market in Europe and Japan under the Lyfnua brand name, and less than two years after the FDA first rejected it in January […]

December 19, 2023

Cinnamon samples gathered at a facility in Ecuador linked to tainted applesauce pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards, according to U.S. Food and Drug Administration inspectors. Tests conducted at […]

December 19, 2023

Checkpoint Therapeutics’ late entry into the PD-1/PD-L1 inhibitor category, cosibelimab, just got knocked back even further after it was turned down by the FDA as a treatment for skin cancer. A complete response letter (CRL) from the US regulator cites […]

December 18, 2023

The Genetic Metabolic Diseases Advisory Committee will advise the FDA on products used for the diagnosis, prevention and treatment of genetic metabolic diseases under the Division of Rare Diseases and Medical Genetics, established in 2020. Genetic metabolic diseases are conditions […]

December 14, 2023

Tarlatamab is under review as a treatment for adult patients with advanced SCLC who have disease progression on or after platinum-based chemotherapy, with the FDA due to deliver a decision on the marketing application by 12th June next year. The […]

December 13, 2023

A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD). When announcing the new drug application (NDA) filing […]

December 13, 2023

The candidate, CAN-2409, has specifically been granted the designation for use alongside prodrug valacyclovir to improve overall survival in patients with pancreatic ductal adenocarcinoma (PDAC). CAN-2409 will now benefit from the FDA’s fast-track process, which is designed to improve the […]

December 11, 2023

The results from the phase 3 APPEAR-C3G study showed that Fabhalta (iptacopan) met its primary objective of an improvement of protein in the urine (proteinuria) compared to placebo at six months, setting up filings for regulatory approval. Last week, targeted […]

December 6, 2023

PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life. The disease has […]