OR WAIT null SECS
March 08, 2019
The CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria-Palynziq (pegvaliase).
The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.
FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.
March 07, 2019
Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.
Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
March 06, 2019
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
March 05, 2019
The FDA commissioner plans to leave the agency in April.
March 04, 2019
The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
March 02, 2019
Do patients get what they pay for when they demand cheaper drugs?
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.