FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
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.