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Government Agencies FDA

  • The announcement was one of several by the FDA on Thursday regarding its priorities in 2018 for drug compounding, which involves pharmacists making drugs to meet patients' specific needs. Gottlieb said the FDA is also preparing a new policy to give state boards of pharmacy more flexibility to oversee compounding pharmacies that ship drugs interstate and is...

  • The move follows a dispute between the FDA and the defense department over a provision in the annual defense authorization bill that would have allowed the Pentagon to authorize the emergency use of drugs and medical devices that have not been approved by the FDA. The U.S. Senate and House of Representatives ultimately passed a bill leaving authority to...

  • Jan 16- Eiger BioPharmaceuticals Inc said on Tuesday it would stop development of its blood pressure drug after it failed in a mid-stage study, sending its shares plunging about 46 percent. There are no U.S. Food and Drug Administration- approved drugs to cure the condition, but it can be managed with treatments available in the market. "We have always recognized...

  • Jan 16- The U.S. Food and Drug Administration and Department of Defense launched a program on Tuesday to speed up the development of drugs that could be used by military personnel. The move follows a controversy over whether the Pentagon should be allowed to authorize the emergency use of drugs and medical devices that have not been approved by the FDA.

  • The Food and Drug Administration on Friday approved AstraZeneca PLC's Lynparza for patients with inherited BRCA gene mutations who have undergone chemotherapy. Lynparza will cost $13,886 per month without insurance, according to AstraZeneca. Susan M. Domchek at the University of Pennsylvania's Abramson Cancer Center said in a statement.

  • Jan 11- Pharmaceutical company Endo International Plc said on Thursday it had received a grand jury subpoena from federal prosecutors in Miami seeking documents related to drugs it produces that contain the opioid painkiller oxymorphone. They have generally argued the U.S. Food and Drug Administration approved their products as safe and effective and...

  • WASHINGTON— In a story Dec. 18 about U.S. crackdown on homeopathic medicines, The Associated Press reported erroneously that the Food and Drug Administration ordered the maker of Zicam to stop marketing several nasal products in 2009. The company voluntarily recalled the products after the FDA issued it a warning letter. WASHINGTON— U.S. health officials plan...

  • **Diagnostic test maker's shares up as much as 64.77 pct to touch record high of $7.25- biggest intraday pct gain since May 2016. **Says China's Food and Drug Administration approved colorectal screening test to help identify the early warning signs of colorectal cancer, also known as bowel cancer. **About 376,000 new cases of colorectal cancer were reported...

  • Jan 5- Amgen Inc said on Friday that the U.S. Food and Drug Administration approved its drug, Xgeva, to prevent fractures in patients with multiple myeloma. The deal gave the drugmaker rights to sell in 48 countries, including Australia as well as markets in Asia, South America and Europe. Xgeva is one of Amgen's key growth drivers and had raked in $1.53 billion in...

  • Dr. Gottlief: FDA's goal is to get generic drugs approved faster

    Dr. Scott Gottlieb, FDA commissioner, talks to CNBC's Meg Tirrell about ways to improve the review process for generic drugs, and the agency's agenda in 2018.

  • Jan 3- Spark Therapeutics Inc said on Wednesday it will charge $850,000 per patient for its breakthrough gene therapy to treat a rare form of blindness, a lower than expected price that the company said reflects patient and insurer concerns about access and cost. The product, approved in December by the Food and Drug Administration, is the first U.S.-approved...

  • The partnership comes at a time when gene therapy is gaining momentum, after several high profile failures in the late 1990 s and early 2000 s, with the U.S. Food and Drug Administration recently updating guidance to help speed up development of such treatments. Under the terms of the deal, Sangamo will receive a $12 million upfront payment from Pfizer and an...

  • FDA approves 46 novel drugs versus 22 in 2016. LONDON, Jan 2- U.S. drug approvals hit a 21- year high in 2017, with 46 novel medicines winning a green light-- more than double the previous year-- while the figure also rose in the European Union. U.S. Food and Drug Administration Commissioner Scott Gottlieb has hailed these products as "a whole new scientific paradigm for...

  • Dec 29- Mylan NV said the U.S. Food and Drug Administration had granted it the approval for a generic version of Allergan's Estrace cream for vaginal atrophy. The approval comes amid the FDA's efforts to speed to market generic versions of complex drugs such as Mylan's own EpiPen, an emergency allergy shot. "Topicals like Estradiol Vaginal Cream are a great...

  • Dec 22- Ocular Therapeutix Inc said on Friday the U.S. Securities and Exchange Commission had issued a subpoena seeking information about the company's eye-pain drug Dextenza. The subpoena included a request to furnish Dextenza-related communications with the U.S. Food and Drug Administration, investors and others, the company said. Dextenza was twice...

  • Dec 22- The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems. The FDA said in a statement that it is proposing to allow the manufacturers to report certain malfunctions in summary reports, rather than...

  • Dec 22- The U.S. Food and Drug Administration on Friday proposed a new program to streamline the reporting of medical device malfunctions by manufacturers. "While manufacturers must report certain device malfunctions to the FDA, these individual reports often describe the same problem, creating a process where the FDA conducts duplicate reviews of common...

  • In 2013, the FDA rejected Twirla, citing efficacy issues and sought additional clinical data. The company also pointed out that an amendment addressing the regulator's concerns about the manufacturing facility and issues related to quality adhesion test methods was not reviewed before the FDA decided to reject the drug. The amendment was submitted on Dec 1,...

  • Dec 22- Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve the company's contraceptive patch due to deficiencies related to its quality adhesion test methods. The CRL did not identify any issues related to the safety of the drug, Agile said, adding that it intends to request a meeting with the FDA to address all the...

  • Dec 22- Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve the company's contraceptive patch, citing deficiencies related to its adhesion test methods. The health regulator also said that the company would have to resolve the observations found during inspection of third-party manufacturing facility, Corium...