Regulatory
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.
Eisai Co., Ltd. has obtained the approvals of supplementary new drug applications in Japan for its in-house developed antiepileptic drug Fycompa for an additional indication for monotherapy of partial-onset seizures and an additional indication for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.
Coherus BioSciences, Inc. announced the Company has entered into a licensing agreement with Innovent Biologics, Co., Ltd.,, a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® in the United States and Canada.
The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
Pharming Group N.V. announced it has received European Medicines Agency approval of a Type II Variation for a new production facility for the Company’s lead product, RUCONEST®.
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.
January isn’t a particularly busy month for PDUFA dates for the U.S. Food and Drug Administration, with only two scheduled for the month. Here’s a look.
Posimir is a non-opioid being developed for post-surgical pain. It is designed to be injected into the surgical site, where it delivers bupivacaine for up to three days post-surgery.
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