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Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an outside group of advisers to evaluate it as well.
The FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.
1, 2023 -- A new gene therapy for sickle cell disease was deemed safe by a U.S. The FDA had already decided that the. WEDNESDAY, Nov. Food and Drug Administration advisory panel on Tuesday, paving the way for full approval by early December.
since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease. The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S.
The agency cleared CSL’s hereditary angioedema drug days after “resource constraints” delayed a rival medicine. Elsewhere, Intellia revealed new data and Lilly beefed up an online service offering access to Zepbound.
FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.The condition is.
THURSDAY, Feb. 6, 2025 -- The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with.
Elsewhere, Angelini Pharma licensed a rare disease therapy and the FDA refused to review a Savara lung drug. City will receive $46 million from Biogen under the alliance.
The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.
Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.
FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,
Food and Drug Administration (FDA) for clinical trials for the treatment of amyotrophic lateral sclerosis (ALS) -- improves neuron health in animal models of Alzheimer's disease, according to a new study. Experimental drug NU-9 -- a small molecule compound approved by the U.S.
A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.
The proposed acquisition is a bet on CymaBay’s drug seladelpar, which is now under FDA review in a chronic liver disease called primary biliary cholangitis.
FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is.
MONDAY, March 24, 2025 -- The U.S. Food and Drug Administration has approved Tremfya (guselkumab) for adult patients with moderately to severely active Crohn disease.This approval is the fourth indication for this dual-acting interleukin-23.
Food and Drug Administration on Friday approved the first diagnostic at-home test to spot the bacterial disease."This FRIDAY, Aug. 16, 2024 -- As syphilis cases surge throughout the United States, the U.S. This is the first at-home, over-the-counter.
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
18, 2024 -- Women with early stage breast cancer may now take Kisquali, a medication already approved for advanced disease, following the U.S. WEDNESDAY, Sept. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis.
Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.
Centers for Disease Control and Prevention and the U.S. TUESDAY, June 17, 2025 -- The U.S. Food and Drug Administration have issued a Salmonella outbreak alert linked to pistachio cream.The The agencies, in conjunction with public health officials in t.
The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.
Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization against invasive meningococcal disease (IMD), according to a press release from. TUESDAY, Feb. 18, 2025 -- The U.S.
According to the company, FDA officials have signaled openness to using a surrogate endpoint for assessing accelerated approval of a treatment for limb-girdle muscular dystrophy.
Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology. FRIDAY, Dec. 8, 2023 -- The U.S. Casgevy, developed by Vertex.
The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.
TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.
Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company.Omvoh targets. THURSDAY, Jan. 16, 2025 -- The U.S.
clearance of Lenmeldy, for a rare and inherited metabolic disease, triggers an additional payout related to Kyowa Kirin’s recent deal to acquire the once high-flying gene therapy developer.
The company claims the results support exploring the possibility of an accelerated approval, citing flexibility by FDA officials in reviewing rare disease gene therapies.
The clearance of Voydeya as an add-on therapy for an uncommon blood disease validates a bet Alexion made on original developer Achillion five years ago.
The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, which hasn’t yet proven it can improve outcomes in kidney disease.
TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.
Centers for Disease Control and Prevention and Food and Drug Administration, the American Cancer. FRIDAY, Feb. 14, 2025 -- With certain government data currently being withheld, removed, or restored but partially redacted on the websites of the U.S.
Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs. By Sarah Wicks & James E.
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