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News & Events

FDA approves first treatment for chronic rhinosinusitis with nasal polyps

Wed, 2019-06-26 14:27
FDA approves Dupixent to treat adults with nasal polyps accompanied by chronic rhinosinusitis or prolonged inflammation of the sinuses and nasal cavity.

Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

Tue, 2019-06-25 14:21
Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

Tue, 2019-06-25 11:21
FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC– for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

Fri, 2019-06-21 17:05
FDA approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

Fri, 2019-06-21 14:04
FDA expanded the indication for Symdeko for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.

Statement on agency’s efforts to increase transparency in medical device reporting

Fri, 2019-06-21 11:01
The FDA is taking a number of important steps to update its Medical Device Reporting Program.

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

Thu, 2019-06-20 10:53
FDA issues a new draft guidance on the application of the benefit-risk assessment framework for evaluating applications for opioids.

Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

Tue, 2019-06-18 13:44
FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).

Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

Tue, 2019-06-18 10:44
This is a statement regarding the FDA’s new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products.

FDA approves new treatment for pediatric patients with type 2 diabetes

Mon, 2019-06-17 16:34
: FDA approves Victoza (liraglutide) injection for pediatric patients with type 2 diabetes. Victoza creates the same effect as GLP-1 receptor protein and is the first non-insulin drug approved since metformin in 2000.

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Fri, 2019-06-14 16:20
Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

Tue, 2019-06-11 16:02
FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Tue, 2019-06-11 10:01
FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Mon, 2019-06-10 12:59
FDA approved Polivy in combination with the chemotherapy bendamustine and a rituximab product to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

Fri, 2019-06-07 15:46
FDA permits marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.

Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

Fri, 2019-06-07 15:46
Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day

FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

Fri, 2019-06-07 12:46
FDA and FTC cite four firms that make or sell several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf.

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

Wed, 2019-06-05 20:25
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

Tue, 2019-06-04 17:18
FDA approves new use of Emgality to treat episodic cluster headache

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