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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The U.S. Food and Drug Administration (FDA) granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes. This designation provides companies more support and the possibility of shorter development and review timelines.
The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.
The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.
The agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more previous system therapies, at least one for metastatic disease.
Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.
The U.S. Food and Drug Administration approved two new treatments for multiple myeloma and pulmonary hypertension.
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.
Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
This morning, Janssen announced Ponvory has been greenlit as the only oral disease-modifying therapy studied against an established oral comparator for this indication.