FDA, opioid

FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under the brand name Journavx.
FDA approves first new class of painkiller in 20 years, a non-addictive opioid alternative
The medication offers relatively modest pain relief, underscoring the challenges of finding new ways to manage pain.
What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of opioids.
FDA approves opioid-free pain medication with 'no sign of addiction'
A new opioid-free pain medication was approved by the FDA on Thursday, marking a non-addictive alternative for patients. Doctors share what patients should know about the drug.
FDA approves Vertex non-opioid pain drug
The FDA's approval of the non-addictive painkiller Journavx last week marked a milestone in the field of pain management. Why it matters: Millions of Americans with acute and chronic pain are prescribed opioids,
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin. The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often follows surgery or injuries.
New type of non-opioid pain medication approved by FDA
The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class non-opioid analgesic to treat acute pain in adults. “Today’s approval is an important public health milestone in acute pain management,
BioSpace12h
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
CNN3d
FDA approves first new type of pain medication in 25 years
“This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain ...
FiercePharma3h
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
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Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative ...
BioSpace11d
FDA Tacks Boxed Warning on Teva’s Copaxone, Other MS Drugs
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
FDA approves HCW Biologics trial for alopecia treatment
MIRAMAR, Fla. - HCW Biologics Inc. (NASDAQ: HCWB), a clinical-stage biopharmaceutical company with a market capitalization of approximately $12.4 million, announced today that it has received U.S.
Day One Biopharmaceuticals: A Successful Launch In Pediatric Cancer
Day One Biopharma's OJEMDA FDA approval for pediatric glioma, but market concerns remain. Check out why I rate DAWN stock as ...