FDA
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
For the millions of people suffering from an allergy to peanuts, there is a new, first-of-its-kind treatment available. On Friday, the U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy AR101.
Although January was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
Dificid is a macrolide antibiotic that was previously approved for CDAD in adults.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma.
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.