FDA Newsfeed

… , now that its received the FDA’s breakthrough designation, Karlin said … that we can go to FDA with statistically clinically significant results …

… US Food and Drug Administration (FDA) breakthrough status designation for its … Disorder (PTSD). Following the US FDA breakthrough status designation, the company …

Annual market sales for Voltaren® Gel, 1% for the 12 months ending March 2019 were approximately $350 million as measured by IQVIA™. Perrigo will manufacture diclofenac sodium topical gel 1% in its plant in Israel. The product was developed through its …

… .S. Food and Drug Administration (FDA) has scheduled the End-of … have treatment resistant depression. The FDA approval of Spravato® (intranasal esketamine …

… and independent studies. An FDA spokeswoman issued a similar … leads. In March, then-FDA Commissioner Dr. Scott Gottlieb announced … Device Events, which scrutinizes FDA adverse event reports. The … To suggest that the FDA and Medtronic somehow conspired …

… top selling cancer drug Tagrisso. FDA Approval Opens Up New Option … for Diabetics The FDA approval for Qternmet XR is … of $630 million. Conclusion The FDA approval of Qternmet XR as … looking to also update its FDA label for Farxiga to include …

… recorded in a public-facing FDA database called MAUDE (Manufacturer … Fidelis. Since 2016, the FDA’s repository accrued at least … . After learning that the FDA had granted Medtronic a MAUDE … repository and ending exemptions. Former FDA official Dr. S. Lori Brown …

… Regional Food and Drugs Authority (FDA) and the Customs Excise … there was strong cordiality between FDA and CEPS base commands … country. Mr Akurugu said FDA is collaborating with the Ghana … deceit. He disclosed that FDA and relevant agencies are investigating …

… announced that they had obtained FDA approval for their drug Bavencio … of safety issues. This FDA approval gives advanced kidney cancer … as well. Conclusion The FDA approval for Bavencio in combination … that have also received FDA approval for the very …

… acquire ProActive Nutra, a GMP, FDA compliant CBD, mushroom and herbal …

… .S. Food and Drug Administration (FDA). ABO-202 is designed to … Pediatric Disease designations by the FDA and has received Orphan Medicinal … numerous regulatory designations from the FDA and EMA for its pipeline …

… .S. Food and Drug Administration (FDA) has approved the commercialization of … were also approved by the FDA, including two market firsts. “Quotient … has more than tripled our FDA approved product offering since coming …

… in bacterial isolates with the FDA, with clearance expected by the … 510(k) filed with the FDA Price Accelerating the identification of … 12–18 months will be FDA 510(k) clearances for the …

… US Food and Drug Administration (FDA) Premarket Approval (PMA) for the … Stryker added that the US FDA PMA approval was granted based …

… .S. Food and Drug Administration (FDA) approved extending the indication of … 2019 Related Articles: Gattex (teduglutide) FDA Approval History

Qiagen N.V announced the US launch of its QIAstat-Dx syndromic testing system after receiving 510(k) clearance by the US Food and Drug Administration, along with the multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and …

… Food and Drug Administration (FDA) has approved Venclexta (venetoclax) … lymphoma (SLL).1 The FDA granted Breakthrough Therapy designation … application. "This FDA approval provides a new … (2018). Approved Drugs: FDA approves venetoclax in combination for …

… PFE) was able to obtain FDA approval for its drugs by … for both Vyndaqel and Vyndamax. FDA Approval Puts Company In Good … Position The FDA approvals of Vyndaqel (tafamidis meglumine … 39;s drug. Conclusion The FDA approval of Vyndaqel and Vyndamax …

… apply sunscreen, but the FDA has found that certain sunscreens … at levels far exceeding the FDA’s recommended threshold. Researchers … levels higher than the FDA threshold without a government … other three chemicals. The FDA and other health officials recommend …

… .S. Food and Drug Administration (FDA) for Azelastine Hydrochloride Nasal Spray …

… the unauthorized marketing, the FDA cited diabetes management devices using … displayed glucose level. “The FDA has not evaluated the … health researchers themselves, the FDA still wants consumers and health … Shuren, director of the FDA’s Center for Devices and …

… Taiwan Food and Drug Administration (FDA) announced Monday, due to … children under two years old. FDA official Huang Chyn-liang (黃琴喨) … Canada, Taiwan's FDA required labels of marketed benzocaine … 2018, the U.S. FDA warned against using products containing …

… any. Last week, the FDA issued a triclosan consumer safety … antibiotic resistance.” However, the FDA indicated it also does not … preventing gingivitis. Recently, the FDA issued a ban of … ingredient list. Additionally, the FDA indicated the agency continues to …

… announced that the U.S. FDA has cleared the company’s … .S. Food and Drug Administration (FDA) has cleared the company’s … _corp_receives_ind_clearance_from_fda_for_its_msc_derived_extracellular …