Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
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.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Gilead Sciences scored a legal victory regarding fraudulent HIV reimbursements, securing a court order against a number of clinics, labs and prescribers in Florida that were engaging in the alleged fraud.
The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
More than two years into the COVID-19 pandemic, some experts, business leaders and government agencies are starting to prep for the next potential pandemic.
Axsome Therapeutics received good news regarding its NDA for AXS-05, a treatment for depression, and Aytu BioScience received Fast Track designation for its VEDS treatment.
Pharma giant Moderna has shared data on the development of a new bivalent COVID-19 booster vaccine that performs better than its first booster that is currently on the market.
There are very few ongoing clinical trials on treatments for Long COVID and there has been what appears to be a successful treatment using Pfizer’s Paxlovid. Read on for more details.
TG Therapeutics voluntarily withdrew its pending BLA and supplemental NDA for its treatment dubbed U2 for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
McKinsey & Company is under fire for allegedly allowing its employees to work simultaneously for big pharma companies and serve as consultants for the U.S. Food and Drug Administration.
The SEC added 12 China companies to their delisting watchlist this week. The companies will need to release evidence by May 3 to remain listed.
The FDA issued new guidance urging drugmakers to submit racial and minority recruitment plans when designing their studies.