API Warning Letters Each spring, the FDA publishes data on its website related to Form 483 inspection observations and warning letters issued by the Centre for Drug Evaluation and Research (CDER) during
Tag "FDA"
The FDA has approved Bydureon BCise for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines. AstraZeneca has announced that the US Food and Drug Administration
A study by the U.S. Food and Drug Administration has backed up Aerie Pharmaceutical’s evidence that its experimental drug is effective in treating glaucoma. According to Reuters, the results were from a
University of Liverpool researchers, working with F2G Limited (Eccles, Manchester), have developed a new antifungal drug to help in the treatment of life threatening invasive fungal infections such as invasive aspergillosis.
The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines. Complex drugs
The Food and Drug Administration is requiring manufacturers of the most widely prescribed painkillers to provide extensive training to doctors in an attempt to reduce the number of patients who
UCB has announced that the European Commission (EC) has approved expanding the use of its anti-epileptic drug (AED) Vimpat (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset
The Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for production of the formulated bulk substance (N-acetylgalactosamine 6-sulfatase (GALNS) used
Impax Laboratories, Inc., a specialty pharmaceutical company, announced it has received final U.S. Food and Drug Administration (FDA) approval for a generic version of Vytorin (ezetimibe/simvastatin tablets), 10/10, 10/20, 10/40 and 10/80
Contrary to some political claims, the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than European regulators did in recent years, new research shows. “It’s
Newron, an Italian biotech focused on CNS diseases, is on a roll. The latest win? FDA approval of its Parkinson’s drug, Xadago. Just in time for World Parkinson’s Day on
Novartis has received FDA approval for Kisqali, a first-line treatment for breast cancer originally developed by the British biotech Astex Pharmaceuticals. The oncology company Astex Pharmaceuticals, located in Cambridge’s biotech hub, entered
Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has
Regulators on both sides of the Atlantic are reviewing three new submissions for medicines containing ertugliflozin, an investigational SGLT2 inhibitor being developed by Merck and Pfizer to help improve glycaemic
In a landmark decision, the United States FDA and the European Commission announced on March 2, 2017 that they will recognize each other’s inspection assessments at pharmaceutical manufacturing facilities. The Mutual
FDA’s Office of Generic Drugs (OGD) released their 2016 Annual Report on Feb. 24, 2017. The report details the office’s accomplishments for the year, including the most-ever approved (630) or tentatively
Amgen announced that the European Commission (EC) has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. The new automated mini-doser (AMD) with a
The company has entered into a three-year agreement with Valeant Pharmaceuticals Ireland for the distribution in Europe, the Middle East and North Africa Sobi has announced that the company has
Developer of consumer healthcare products, Leman Micro Devices (LMD) has announced that its Health Sensor & App will be submitted to the FDA for approval. The app allows users to
On Feb. 2, 2017, FDA issued a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found current good manufacturing practices (CGMP) violations at the company’s Tokyo facility. Violations found
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