News
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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Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
The latest data from Merck and Ridgeback Biotherapeutics’ MOVe-OUT trial on the use of molnupiravir to treat COVID-19 in adults has shown a lower efficacy than previously reported.
Treatment for non-alcoholic steatohepatitis (NASH), a severe form of fatty liver disease, consists mainly of lifestyle modification – specifically dieting and weight loss.
Thanksgiving week was marked by numerous clinical trial announcements. Here’s a look.
The U.S. Food and Drug Administration has a very busy calendar for the end of November and beginning of December. Here’s a look.
Bonus BioGroup’s product is back in the news again as its cell therapy promises to treat late-stage COVID-19.
Both Gilead Sciences and Merck announced they were pausing a Phase II trial of islatravir and lenacapavir in HIV.
A cardiovascular drug Pfizer licensed from Akcea Therapeutics in 2019 hit the mark in a Phase IIb dose-ranging study in patients with elevated non-HDL-C and triglycerides.
Although vaccines and effective therapeutics are powerful tools in preventing and treating COVID-19, we’re not done battling the disease just yet. For those stories and more, read on.
The precision medicine company is developing mutant selective and isoform-specific drugs in non-conventional ways for well-known targets in the oncology and autoimmune spaces.
Shares of Kura Oncology have plunged nearly 30% in premarket trading after the FDA placed a partial clinical hold on the company’s Phase Ib leukemia study following the report of a patient’s death.