FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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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Novartis released new information that showed siponimod consistently reduced the risk of confirmed disability progression in secondary progressive multiple sclerosis (SPMS) patients.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations.
In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.
Shares of Rigel Pharmaceuticals shot up about 40 percent during Thursday trading due primarily to an error on the company’s website that claimed its drug candidate Tavalisse had gained approval from the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved Amgen’s supplemental Biologic License Application (sBLA) for Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) under specific circumstances.
The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients.This marks the third HIV approval for the company.
The U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for a type of colorectal cancer.
Seattle Genetics announced today that the FDA has granted approval for its Adcetris drug to treat Hodgkins Lymphoma.
The FDA granted a Priority Review designation to Pfizer and partner Astellas Pharma for expanded use of Xtandi in prostate cancer treatment.
On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly’s re-submission for their moderate-to-severe rheumatoid arthritis drug.