FDA, Vertex Pharmaceuticals

FDA approves Vertex's first-in-class non-opioid analgesic for acute pain
Today, the U.S. Food and Drug Administration (FDA) gave its approval to Vertex Pharmaceuticals' (NASDAQ: NASDAQ:VRTX) Journavx (suzetrigine) 50 milligram oral tablets. This new drug is a non-opioid analgesic,
First New Non-Opioid Painkiller in Decades Gets FDA Approval
Vertex Pharmaceuticals won U.S. approval for the first new non-opioid painkiller in decades, which could be a blockbuster if the company can persuade insurers and doctors to embrace the non-addictive alternative to notorious drugs like OxyContin.
Vertex Pharmaceuticals’ non-opioid Journavx approved for pain by FDA
Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class
Vertex gets FDA approval for non-opioid pain reliever
Shares of Vertex Pharmaceuticals (NASDAQ:VRTX) rose 3% in post-market trading Thursday on news the company had received FDA approval for its non-opioid pain reliever Journavx, also known as suzetrigine.
US FDA approves Axsome Therapeutics' migraine drug
The U.S. Food and Drug Administration has approved Axsome Therapeutics' migraine treatment, the company said on Thursday. The oral drug, branded Symbravo, was approved for the acute treatment of the condition characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head.
Vertex Pharmaceuticals announces FDA approval of Journavx
Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration has approved JOURNAVX, an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor
Axsome gets FDA approval for Symbravo for migraine
Axsome Therapeutics (NASDAQ:AXSM) has received FDA approval for its drug Symbravo for the acute treatment of migraine with or without aura in adults. Symbravo, a combination of meloxicam and rizatriptan,
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will be sold under the brand name Journavx.
Axsome Therapeutics announces FDA approval of Symbravo
Axsome Therapeutics (AXSM) announced that the U.S. FDA has approved Symbravo for the acute treatment of migraine with or without aura in
Biotech Stocks Facing FDA Decision In February 2025
February is observed as American Heart Month, a period dedicated to raising awareness about heart health. The first American Heart ...
2 Healthcare Stocks You Can Buy Right Now Before They Surge Even Higher
Generally, you can count on drugmakers for a steady revenue performance -- since patients need their medicines, revenue holds ...
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...
Atara to cut 50% of workforce amid FDA woes
Atara Biotherapeutics (NASDAQ:ATRA) has announced plans to cut around 50% of its workforce, just a little over a week after it said the FDA had declined to approve its immunotherapy Ebvallo. The ...
Merck: FDA grants priority review to sNDA for Welireg
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
Vanda Pharmaceuticals seeks FDA nod for motion sickness drug
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $256.56 million and impressive gross profit margins of 93.62%, disclosed through a social media post ...
FDA accepts Teva, Alvotech BLAs for Simponi biosimilars
Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review of the applications is expected to by completed in Q4 2025, ...
Strong Outlook for Cartesian Therapeutics: FDA SPA Agreement and Positive Phase 2b Results Boost Confidence in Descartes-08
Mitchell Kapoor, an analyst from H.C. Wainwright, reiterated the Buy rating on Cartesian Therapeutics (RNAC – Research Report). The associated ...