Isotopia Molecular Imaging is pleased to announce that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for no-carrier-added Lutetium-177 (n.c.a. Lu177), a medical radioisotope.
FDA sets PDUFA date of December 30, 2020
Changes would provide greater flexibility to respond to surge demands and ensure that needed medications are readily available for patient care.
Orphazyme expects to submit MAA for arimoclomol for NPC to European Medicines Agency in the second half of 2020
Phase 1 Dose-Escalation Trial in Therapy-Refractory Solid Tumors to Begin in 2020
Agency Continues Effort to Protect Public Health from Fraudulent and Harmful Products
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.
.jpg){kind=tracking}
Polaryx Therapeutics, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of LINCL patients with PLX-200.
Camurus AB (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request (through Citizen Petition) to revoke orphan drug designation of Sublocade™.
One of the U.S. Food and Drug Administration's top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for a number of reasons, shortages of certain medicines occur and the FDA works immediately with our public health partners and industry to minimize their impact on patients and restore the availability of these drugs.
Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.
Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.
Civica Rx partnership helps ensure essential, affordable, accessible generic medicines
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility