Tag Archives: FDA

Alnylam gets surprise FDA rejection for rare disease drug – Boston Business Journal – The Business Journals

  1. Alnylam gets surprise FDA rejection for rare disease drug – Boston Business Journal The Business Journals
  2. Alnylam abandons Onpattro expansion in US as FDA spurns rare heart disease bid FiercePharma
  3. FDA rejects Alnylam’s request to expand approval of one of its drugs to include heart patients The Boston Globe
  4. Alnylam gives up on expanded use of heart-disease drug in US after FDA declines approval Yahoo News
  5. Alnylam Announces Receipt of Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis Business Wire

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After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy’s Alfasigma – FiercePharma

  1. After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy’s Alfasigma FiercePharma
  2. Intercept, once a biotech trailblazer, sells itself for less than $1 billion STAT
  3. Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver Diseases Yahoo Finance
  4. Why Intercept Pharmaceuticals Stock Is Skyrocketing Today The Motley Fool
  5. Why Is Intercept Pharmaceuticals (ICPT) Stock Up 75% Today? InvestorPlace
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Major Trial Finds MDMA-Assisted Therapy Is Effective for PTSD, Paving Way for FDA Approval – Gizmodo

  1. Major Trial Finds MDMA-Assisted Therapy Is Effective for PTSD, Paving Way for FDA Approval Gizmodo
  2. Psychedelic drug MDMA eases PTSD symptoms in a study that paves the way for possible US approval The Associated Press
  3. MDMA Therapy for PTSD Inches Closer to U.S. Approval The New York Times
  4. MDMA-Assisted Therapy Demonstrates Significant Reductions in Post-Traumatic Stress Disorder Symptoms in Phase 3 Study Pharmacy Times
  5. After Latest Clinical Trial, MDMA Therapy For PTSD Is ‘On Track’ For FDA Consideration Next Year Marijuana Moment
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Stuffy or runny nose? Don’t bother using popular nasal decongestant: US FDA – Global News

  1. Stuffy or runny nose? Don’t bother using popular nasal decongestant: US FDA Global News
  2. Decongestant found in Sudafed PE, Vicks Dayquil and others doesn’t work, FDA panel says. Here’s why and what you should use instead of phenylephrine. Yahoo Life
  3. FDA says popular decongestant doesn’t work | WNN ABC News
  4. FDA: Phenylephrine, ingredient found in decongestants, determined to be ineffective CBS Pittsburgh
  5. Popular nasal decongestants like Sudafed, NyQuill are ineffective, FDA says | LiveNOW from FOX LiveNOW from FOX
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Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma – PR Newswire

  1. Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma PR Newswire
  2. Delcath Systems (NASDAQ:DCTH) Skyrockets on FDA Approval for Hepzato Liver Therapy – TipRanks.com TipRanks
  3. Delcath Systems Stock Is Rocketing Higher: What’s Going On? – Delcath Systems (NASDAQ:DCTH) Benzinga
  4. Why Is Delcath Systems (DCTH) Stock Up 72% Today? InvestorPlace
  5. Persistence pays for Delcath as cancer treatment Hepzato Kit finally scores FDA nod FiercePharma
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Sage suggests job and pipeline cuts after FDA rejection of major depression pill – Endpoints News

  1. Sage suggests job and pipeline cuts after FDA rejection of major depression pill Endpoints News
  2. Sage Therapeutics stock plunges more than 50% after FDA denies wider use of postpartum depression drug CNBC
  3. Sage Therapeutics’ stock drops 49% after FDA approves zuranolone for postpartum depression but not for major depressive disorder MarketWatch
  4. Why Sage Therapeutics Shares Are Sinking Monday – Sage Therapeutics (NASDAQ:SAGE) Benzinga
  5. Sage Therapeutics Announces Second Quarter 2023 Financial Results and Highlights Pipeline and Business Progress Yahoo Finance
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Sage Therapeutics’ stock drops 49% after FDA approves zuranolone for postpartum depression but not for major depressive disorder – MarketWatch

  1. Sage Therapeutics’ stock drops 49% after FDA approves zuranolone for postpartum depression but not for major depressive disorder MarketWatch
  2. Sage Therapeutics stock plunges more than 50% after FDA decision on postpartum depression drug CNBC
  3. Sage Stock: Why The Biotech Lost Half Its Value After The FDA Approved Its Depression Drug Investor’s Business Daily
  4. Sage Therapeutics Announces Second Quarter 2023 Financial Results and Highlights Pipeline and Business Progress Yahoo Finance
  5. Why Sage Therapeutics Shares Are Sinking Monday – Sage Therapeutics (NASDAQ:SAGE) Benzinga
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FDA clears Braeburn’s long-acting Brixadi to treat opioid use disorder – FiercePharma

  1. FDA clears Braeburn’s long-acting Brixadi to treat opioid use disorder FiercePharma
  2. FDA Approves Braeburn’s Brixadi Injection to Treat Moderate-to-Severe Opioid Use Disorder Pharmacy Times
  3. Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder PR Newswire
  4. Indivior’s Opvee crosses FDA finish line, adding new overdose rescue option amid raging opioid epidemic FiercePharma
  5. FDA Approves Buprenorphine Injection for Opioid Use Disorder Medscape
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New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval – Yahoo! Voices

  1. New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval Yahoo! Voices
  2. Decision made on RX nasal spray for opioid overdoses WJW FOX 8 News Cleveland
  3. New overdose antidote approved, but concerns raised about cost, side effects The Washington Post
  4. Indivior’s Opvee crosses FDA finish line, adding new overdose rescue option amid raging opioid epidemic FiercePharma
  5. Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder PR Newswire
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FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy – STAT

  1. FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy STAT
  2. Krystal’s Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease FiercePharma
  3. Rare Skin Blistering Condition Gets First Drug Approved Medpage Today
  4. Landmark victory for individuals living with DEB and their families, the FDA announced their approval of Krystal Biotech’s VYJUVEK™ for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Business Wire
  5. FDA Approves First-Ever Topical Gene Therapy Medscape
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