Experts decry FDA’s halting of a high-profile Covid-19 study over approvals
Regulators at the Food and Drug Administration told STAT the agency’s decision this month to halt a high-profile, Bill Gates-backed effort to study the spread...
Tag: Approvals
STAT Plus: Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals
A version of this article first appeared in D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here...
STAT Plus: An FDA tool for hastening approvals is not very useful for breast cancer drugs
Nearly two years ago, the Food and Drug Administration published a table of surrogate endpoints that drug developers could reference as they chart a course...
A quarantined Ted Cruz proposes to speed approvals for coronavirus drugs and vaccines
Although Sen. Ted Cruz (R-Texas.) is quarantined at home after coming into contact with someone who tested positive for Covid-19, the lawmaker plans to introduce...
Innovation Marks New Drug Approvals in 2019 and 2020
The hallmark of drug approvals in 2019 and expected approvals for 2020 is innovation. More than 40% of new drugs were for orphan diseases that...
The Year in Drug Approvals: Specialty Still Leads the Pack
National Harbor, Md.—The FDA has approved 41 novel drugs, eight biologics and nine biosimilars so far in 2019, which is far below 2018’s record-breaking 59...
STAT Plus: Most Americans misunderstand approvals and FDA’s role in overseeing drug ads
The Food and Drug Administration may be a high-profile government agency, but a new survey finds that a notable portion of Americans are confused about...
STAT Plus: Pharmalittle: Trump proceeds with plan to allow importation; most Americans misunderstand FDA approvals
Hello, everyone, and how are you today? We are doing just splendidly, thank you, despite the icy frost that has descended on the Pharmalot campus....
STAT Plus: EMA adopts EU Ombudsman recommendations to avoid bias concerns over drug approvals
Seeking to end another flap about transparency, the European Medicines Agency has agreed to recommendations made by the European Ombudsman to ensure that private talks...
FDA Town Hall: New Drug Approvals in Gastrointestinal Disease (2018-2019)
FDA Town Hall: New Drug Approvals in Gastrointestinal Disease (2018-2019) Source link...
Nearly half of NCI-sponsored trials on clinical cancer were associated with new drug approvals
A new study shows that nearly half of phase 3 cancer clinical trials carried out by the National Cancer Institute (NCI)-sponsored SWOG Cancer Research Network,...
STAT Plus: Flawed trials supported half of recent approvals of cancer drugs in Europe, study says
As drug makers race to bring cancer treatments to market, a new study finds about half of the supporting clinical trials for cancer medicines recently...
STAT Plus: Cancer drug approvals in the U.S. have surged over the past few decades
Reflecting an intensifying effort to conquer cancer, the portion of new oncology treatments approved by the Food and Drug Administration swelled over the past decade,...
STAT Plus: FDA, accused of being too lax in approval of opioids, outlines new criteria for future approvals
The Food and Drug Administration on Thursday outlined the agency’s plans for weighing submissions for new opioid approvals, following criticism that the agency has been...
Budding Growth: Gottlieb Expanded GI Drug Approvals, Fostered Medical Cannabis Development
In the fall of 2016, I was selected to take part in the ACG-FDA fellowship where I was embedded with the Division of Gastroenterology and...
Government shutdown threatens biosimilar approvals, patent litigation
As the ongoing partial government shutdown continues in the United States, the FDA has approximately 5 weeks until drug user fees completely dry up, jeopardizing...
Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals
SOUTHBOROUGH, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/clinicalresearch?src=hash" target="_blank"gt;#clinicalresearchlt;/agt;–Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals Source link...
Global Intracranial Pressure Monitoring Devices Market 2019-2023| Increase in Regulatory Approvals for Products Impacting Market Growth| Technavio
LONDON–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/HealthCareEquipment?src=hash" target="_blank"gt;#HealthCareEquipmentlt;/agt;–The global intracranial pressure monitoring devices market 2019-2023 is expected to post a CAGR of close to 7%, according to Technavio. Source...
Global Traumatic Brain Injury Therapeutics Market 2019-2023| Array of New Drug Approvals to Boost Growth| Technavio
LONDON–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/BrainInjuryTherapeutics?src=hash" target="_blank"gt;#BrainInjuryTherapeuticslt;/agt;–Technavio analysts forecast the global traumatic brain injury therapeutics market to grow at a CAGR of close to 5% during the period,...
The Future of Fatty Liver: From Education to Anticipated Approvals
The increasing prevalence of nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, presents a significant need for therapeutic options. While no specific therapy...