Corbus Pharma (CRBP) Granted FDA Orphan Drug Designation for Lenabasum for the Treatment of Dermatomyositis

Corbus Pharma (CRBP) Granted FDA Orphan Drug Designation for Lenabasum for the Treatment of Dermatomyositis

Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here. Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) announced today that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to lenabasum, its novel, synthetic oral endocannabinoid-mimetic drug, for the treatment of dermatomyositis (“DM”). The […]

Congress and FDA address Over the Counter Drugs

Congress and FDA address Over the Counter Drugs

On the evening of July 16, the House passed a sweeping over-the-counter (OTC) drug regulation reform bill, bringing the first changes to the system in over four decades. The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 would amend the Food and Drug Administration’s (FDA) OTC drug review process by expanding the $8 million […]

FDA issues recall for a drug used for high blood pressure, heart failure

FDA issues recall for a drug used for high blood pressure, heart failure

NATIONWIDE — The Food and Drug Administration announced a voluntary recall for a drug used to treat high blood pressure and heart failure. The agency says there is a voluntary recall of drug products containing valsartan which is used to treat high blood pressure and heart failure. They say some medications contain an impurity classified […]

FDA to Form Workgroup to Study Drug Importation

FDA to Form Workgroup to Study Drug Importation

WASHINGTON — Health and Human Services (HHS) Secretary Alex Azar on Thursday asked the FDA to develop a working group to consider whether importation of certain prescription drugs might help bring drug prices down. “We look forward to working with [FDA] Commissioner [Scott] Gottlieb and the FDA to explore how importation could help address price […]

VERIFY: FDA Email About Your RX Drugs Isn't Real

VERIFY: FDA Email About Your RX Drugs Isn't Real

QUESTION: Is a new scam targeting people who purchase their medications through online pharmacies and over the phone? ANSWER: Yes, the FDA warns this phishing scam could be an international exploitation scheme. SOURCES: FDA press release FDA tweets PROCESS: High prescription drug prices can drive some to cheaper options online, but not all online pharmacies […]

Mersana's cancer drug trial put on hold by FDA; shares halted

Mersana's cancer drug trial put on hold by FDA; shares halted

(Reuters) – Mersana Therapeutics said on Thursday an early stage trial testing its lead cancer drug has been put on partial hold by the U.S. Food and Drug Administration after a patient’s death was possibly linked to the treatment. No new patients will be enrolled in the study, but the current participants will continue to […]

Janssen wins FDA nod for Symtuza but the once-daily HIV drug must now find its place in the market

Janssen wins FDA nod for Symtuza but the once-daily HIV drug must now find its place in the market

Johnson & Johnson has won FDA approval for a new once-a-day HIV drug, adding to its growing portfolio of treatment options for the condition. Now J&J must find a way to distinguish the drug in an increasingly crowded market that includes Gilead Sciences’ hot-selling Biktarvy. J&J’s Janssen drug unit announced that the FDA has approved Symtuza […]

FDA: Patient Access to OTC Drugs to Cut Out-of-Pocket Drug Costs

FDA: Patient Access to OTC Drugs to Cut Out-of-Pocket Drug Costs

By Sara Heath July 19, 2018 – A draft guidance from FDA will help patients navigate over-the-counter (OTC) drug alternatives for some of their usual, prescription chronic disease management drugs. Ideally, this will promote patient choice in their own medications and control some of the out-of-pocket drug costs patients face. “While the FDA doesn’t have a […]

FDA Chief Slams Drug Makers for Stalling Release of Biosimilars

FDA Chief Slams Drug Makers for Stalling Release of Biosimilars

Food and Drug Administration Commissioner Scott Gottlieb on Wednesday accused drug makers who manufacture pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market, costing Americans billions. The tactics—some of which Gottlieb will refer to as a “toxin”—have prevented other drug makers from launching biosimilar medicines, highly similar versions of the same […]