FDA Webview
Human Drugs
FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall s...
Human Drugs
An FDA approval document shows that the accelerated approval of Replimunes Tudriqev came despite sig...
Human Drugs
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated ...
Human Drugs
FDAs Oncologic Drugs Advisory Committee votes to not recommend approval for a Genta NDA for leukemia...
Human Drugs
CDC says FDA has helped manufacturers prepare to ship a record volume of flu vaccine this season.
Human Drugs
Escalon Medical Corp. has discontinued Phase I human clinical trials for its Ocufit SR ophthalmic dr...
Human Drugs
FDA approves Lantheus Holdings Tauklarify (florquinitau F 18 injection) as a PET imaging agent to id...
Human Drugs
Cephalon says it plans to submit an NDA in the third quarter for Treanda, indicated for treating chr...
Human Drugs
Perrigo Company, Allegan, MI, recalled 4,473,600 acetaminophen tablets extra strength, 500 mg, packa...
Human Drugs
Cortex Pharmaceuticals submits a complete response to an FDA clinical hold on its lead Ampakine comp...
Human Drugs
FDA says it has added two days to its fast-track six months review of Texas Biotechnology Corp.'s 8/...
Human Drugs
FDA should not accept or approve new drug applications under Section 505(b)(2) of the Food and Drug ...
Human Drugs
Zonagen submits rat study data on its Vasomax and Vasofem sexual dysfunction drugs as required by FD...
Human Drugs
FDA defers for nine months Johnson & Johnson Merck's compliance with "Drug Facts" labeling format re...
Human Drugs
Five members of Congress ask FDA to distribute information and the government to do more research on...
Human Drugs
FDA approves Pharmacia & Upjohn's new oxazolidinone antimicrobial Zyvox with indications to treat a ...
Human Drugs
CDER posts details on two upcoming workshops in California on Scale-Up and Post Approval Changes (SU...
Human Drugs
Drug industry ads attacking the drug importation bill are rubbish, alleges co-sponsor James Jeffords...
Human Drugs
An industry letter asks FDA to schedule a meeting at the earliest possible time, so it can discuss i...
Human Drugs
Cubist Pharmaceuticals gains FDA's acceptance of its design of Phase III trials for Cidecin, a new a...
