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Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.
Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.
Following a series of stumbles in Type 1 diabetes, Lexicon’s dual SGLT inhibitor sotagliflozin finally won the FDA’s approval in heart failure and will be marketed as Inpefa.
DUO-E trial data show AstraZeneca’s Imfinzi, either alone or in combination with Lynparza, boosts progression-free survival in endometrial cancer.
Eli Lilly’s recently registered Phase IIIb SURMOUNT-5 trial will compare its Mounjaro with Novo Nordisk’s Wegovy in obese or overweight patients with weight-related health conditions.
The New York–based biotech will present data from a Phase I trial of 98 patients showing that fianlimab combined with Libtayo led to an overall response rate of 61% in advanced melanoma.
Bristol Myers Squibb’s Reblozyl induced nearly twice the red blood cell transfusion independence compared with the current standard treatment epoetin alfa for lower-risk myelodysplastic syndrome.
The company will present data at the oncology meeting showing the drug’s significant survival benefit in patients with advanced renal cancer and recurrent, persistent and metastatic cervical cancer.
The Massachusetts-based biopharma became the second company this week to drop its amyotrophic lateral sclerosis hopeful after it failed to elicit significant improvement compared with placebo.
Although still in early-stage testing, Ensysce Biosciences’ formulation has demonstrated the potential to address addiction problems associated with oral oxycodone.