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The Latest Breaking News from FDA

Vertex Pharma's Stem Cell Derived Diabetes Treatment Trial Put On Hold

The FDA has instituted a clinical hold on Vertex Pharmaceuticals Incorporated's (NASDAQ:VRTX) VX-880 Phase 1/2 study due to a determination that there is insufficient information to support dose escalation with the product. VX-880 is an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for type 1 diabetes (T1D). Three patients have been…

Benzinga

Kala Pharmaceuticals Posts KPI-012 Data In Healing Impaired Ocular Diseases

Kala Pharmaceuticals Inc (NASDAQ:KALA) reported data from a Phase 1b trial of KPI-012, a cell-free secretome therapy for severe ocular diseases driven by impaired healing. As previously disclosed, KPI-012 was well tolerated and resulted in significant improvements in various persistent corneal epithelial defect (PCED) etiologies. The data will be presented at the 2022…

Benzinga

Horizon Therapeutics' Inebilizumab Scores European Approval For Spinal Cord Inflammation

The European Commission has approved Horizon Therapeutics plc's (NASDAQ:HZNP) Uplizna (inebilizumab) as monotherapy for neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). NMOSD is an autoimmune disease that attacks the optic nerve, spinal cord, brain, and brain stem. In the N-MOmentum pivotal clinical trial, Uplizna demonstrated a significant reduction…

Benzinga

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FDA Approves Expanded Use Of Supernus' Viloxazine In Adult ADHD Patients

The FDA approved an expanded indication for Supernus Pharmaceuticals Inc's (NASDAQ:SUPN) Qelbree (viloxazine extended-release capsules) for attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for ADHD in children (starting at age 6), adolescents, and adults. Qelbree is a novel non-stimulant taken once daily for…

Benzinga

Sage Therapeutics, Biogen Start Rolling Submission For Zuranolone In Major Depressive Disorder

Sage Therapeutics Inc (NASDAQ:SAGE) and Biogen Inc (NASDAQ:BIIB) have initiated a rolling submission of a marketing application to the FDA for zuranolone in major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug developed for MDD and postpartum depression (PPD). The companies have submitted the nonclinical module and plan to submit the remaining…

Benzinga

31 Stocks Moving In Monday's Mid-Day Session

Gainers Redbox Entertainment Inc. (NASDAQ: RDBX) climbed 64.9% to $9.86. Redbox recently reported CFO transition.

Benzinga

Vaxxinity Gets Fast Track designation from FDA For Alzheimer's disease Candidate UB-311

Vaxxinity, Inc. (NASDAQ: VAXX) announced that UB-311 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease.

Benzinga

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FDA Issues Complete Response Letter (CRL) to Axsome Therapeutics for AXS-07 In Acute Migraine

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Axsome Therapeutics, Inc. (NASDAQ: AXSM) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

Benzinga

Mid-Morning Market Update: Markets Mostly Lower; US Factory Growth Slows In April

U.S. stocks traded mostly lower this morning, with the Dow Jones tumbling around 100 points on Monday.

Benzinga

Coherus and Junshi Biosciences Receive CRL from FDA for Toripalimab in combination with Gemcitabine and Cisplatin In metastatic nasopharyngeal carcinoma (NPC)

Shanghai Junshi Biosciences and Coherus BioSciences, Inc. (NASDAQ: CHRS) received a complete response letter (CRL) from the U.S.

Benzinga

FDA Rejects Junshi - Coherus' Toripalimab For Rare Head & Neck Cancer

The FDA has issued a complete response letter (CRL) to Junshi Biosciences Co Ltd and Coherus BioSciences Inc's (NASDAQ:CHRS) toripalimab application for advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). NPC is a rare tumor of the head and neck which originates in the nasopharynx, located behind the nose and above the back of the throat. The…

Benzinga

As Expected, FDA Rejects Axsome Therapeutics' Migraine Candidate

The FDA has issued a Complete Response Letter (CRL) to Axsome Therapeutics Inc's (NASDAQ:AXSM) AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval…

Benzinga

Myovant Sciences' Relugolix For Hormone-Sensitive Prostate Cancer Approved In Europe

The European Commission (EC) has approved Myovant Sciences Ltd's (NYSE:MYOV) Orgovyx (relugolix, 120 mg) for advanced hormone-sensitive prostate cancer. This approval was supported by data from the Phase 3 HERO study. In the HERO study, Orgovyx met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48…

Benzinga

Why Vertex Pharmaceuticals Shares Are Falling

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) shares are trading lower by 3.42% to $263.88 during Monday’s pre-market session after the company announced VX-880 Phase 1/2 has been placed on clinical hold by the FDA due to “a determination that there is insufficient information to support do

Benzinga

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Benzinga

Zosano Pharma Announces Additional Workforce Layoff

The FDA had granted Zosano Pharma Corporation (NASDAQ: ZSAN) a twelve-month extension to April 20, 2023, to resubmit its M207 marketing application.

Benzinga

FDA Grants Orphan Drug Designation For IDEAYA's Darovasertib For Uveal Melanoma

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to IDEAYA Biosciences (NASDAQ: IDYA) for its drug candidate Darovasertib for the treatment of uveal melanoma.

Benzinga

U.S. FDA Rejects HUTCHMED's New Drug Application For Surufatinib In Neuroendocrine Tumors

HUTCHMED (China) Limited (Nasdaq: HCM) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).

Benzinga

The Week Ahead In Biotech (May 1-7): Phathom FDA Decision, Pfizer, Vertex Pharma Lead Earnings News, Ophthalmology Conference Presentations, And More

Biotech stocks posted weekly declines yet again in the week ending April 29, taking cues from the weak broader market sentiment. Big pharma earnings, clinical readouts and pipeline updates moved stocks during the week.

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Axios

Pressure builds for COVID vaccines approval for littlest kids

Moderna's request for approval of its COVID -19 vaccine in children under six years amps up pressure on the Food and Drug Administration to act quickly to approve the shots.

Tribune News Service

Editorial: The FDA rightly moves to extinguish menthol cigarettes

The Food and Drug Administration has proposed banning menthol-flavored cigarettes, potentially beginning in 2024. It’s a tragedy that it is taking this long, but it’s never too late to save a life — or in this case, potentially hundreds of thousands of lives.

Dynamite News

Radiofrequency spinal cord stimulation shows improved longer-lasting pain relief: Study

According to a new study, chronic pain spinal cord stimulation (SCS) uses an implanted device to supply a small amount of electricity directly to the spinal cord, altering or blocking nerve activity and minimizing the sensation of pain reaching the brain.

Benzinga

QNRX: FDA Clearance To Move QRX003 Clinical Testing Forward; Positive Implications

By M. Marin NASDAQ:QNRX READ THE FULL QNRX RESEARCH REPORT

Benzinga

U.S. FDA Approves AbbVie's RINVOQ® (upadacitinib) for Ankylosing Spondylitis (AS)

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s (NYSE: ABBV) RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) .

Benzinga

FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete. The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE)…

Benzinga

48 Stocks Moving In Friday's Mid-Day Session

Gainers Belite Bio Inc. ADR (NASDAQ: BLTE) shares surged 144.8% to $14.69. Belite Bio priced its 6 million ADS IPO at $6 per ADS.

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