The U.S. Food and Drug Administration approved Chiesi Global Rare Diseases’ Ferriprox (deferiprone) for the treatment of transfusional iron overload caused by sickle cell disease or other anemias in adults and children ages 3 years and older.
The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.
The submission of U.S. approval for AstraZeneca’s Covid-19 vaccine was pushed back to mid-May, with the company citing the massive dataset as the cause.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage. Research has also shown that up to 60 percent of study participants may experience placebo-related analgesic responses and that these responses may be persistent.
Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.
Two new cases of blood clots after administration of Johnson & Johnson’s single-dose Covid-19 vaccine are being investigated by federal health officials, the U.S. Centers for Disease Control and Prevention said on April 27.
