$AMRX News
Last published 1d ago
- 1d agoAMRXAmneal Named BioSpace 2027 Best Place to Work, Ranking No.1 Among Large EmployersGlobeNewswireRecognition marks second consecutive year Amneal has been named a BioSpace Best Place to Work
- 1w agoAMRXAmneal Pharmaceuticals, Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 7.01 Item 9.01
- 1w agoAMRXAmneal Reports Third Quarter 2026 Financial ResultsGlobeNewswire– Q3 2026 Net Revenue of $863 million; GAAP Net Loss of $22 million; Diluted Loss per Share of $(0.06) –– Adjusted EBITDA of $207 million; Adjusted Diluted EPS of $0.26 –– Updating 2026 Full Year Guidance –
- 3w agoAMRXApproval of Mesalamine, Anda #215067 (Labeling)FDA Approved DrugsApproval Date: 10/15/2026; Drug Name: Mesalamine, Anda #215067; Active Ingredients: MESALAMINE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 215067
- 3w agoAMRXApproval of Sodium Phosphates, Anda #218274FDA Approved DrugsApproval Date: 10/15/2026; Drug Name: Sodium Phosphates, Anda #218274; Active Ingredients: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; Company: Amneal; Submission Status: Approval; Application Number: 218274
- 1mo agoAMRXAmneal to Report Third Quarter 2026 Results on November 3, 2026GlobeNewswireBRIDGEWATER, N.J., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), today announced it will report third quarter 2026 financial results on
- 1mo agoAMRXApproval of Exenatide Synthetic, Anda #206697 (Labeling)FDA Approved DrugsApproval Date: 10/02/2026; Drug Name: Exenatide Synthetic, Anda #206697; Active Ingredients: EXENATIDE SYNTHETIC; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 206697
- 1mo agoAMRXApproval of Labetalol Hydrochloride, Anda #218870 (Labeling)FDA Approved DrugsApproval Date: 09/28/2026; Drug Name: Labetalol Hydrochloride, Anda #218870; Active Ingredients: LABETALOL HYDROCHLORIDE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 218870
- 1mo agoAMRXAmneal Announces FDA Approval and Launch of Lanreotide InjectionGlobeNewswire- Expands complex injectables portfolio with important long-acting oncology treatment - Immediate commercial launch supported by in-house production BRIDGEWATER, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Amneal
- 1mo agoAMRXApproval of Lanreotide Acetate, Anda #218217FDA Approved DrugsApproval Date: 09/18/2026; Drug Name: Lanreotide Acetate, Anda #218217; Active Ingredients: LANREOTIDE ACETATE; Company: Amneal; Submission Status: Approval; Application Number: 218217
- 2mo agoAMRXEarnings Call - AMNEAL PHARMACEUTICALS INCEarnings Call TranscriptsJill, tell me about your dad. So... Don't lie. I won't. I only have good things to say. My name is Casper. Lived in Brooklyn all my life. My family is the most important thing to me. It always was and it always will be.
- 3mo agoAMRXAmneal Completes Acquisition of Kashiv BioSciences, Creating a Global Biosimilar LeaderGlobeNewswireEstablishes an integrated global platform spanning biosimilar R&D, manufacturing and commercialization Adds a major long-term growth pillar and extends Amneal’s growth profile into the 2030s BRIDGEWATER, N.J.,
- 3mo agoAMRXAmneal Reports Second Quarter 2026 Financial ResultsGlobeNewswire– Q2 2026 Net Revenue of $796 million; GAAP Net Income of $58 million; Diluted Income per Share of $0.18 –– Adjusted EBITDA of $206 million; Adjusted Diluted EPS of $0.30 –– Raising 2026 Full Year Guidance –– Successful
- 3mo agoAMRXApproval of Mycophenolate Mofetil, Anda #214871 (REMS)FDA Approved DrugsApproval Date: 07/29/2026; Drug Name: Mycophenolate Mofetil, Anda #214871; Active Ingredients: MYCOPHENOLATE MOFETIL; Company: Amneal; Submission Status: Approval; Submission Classification: REMS; Application Number: 214871
- 3mo agoAMRXApproval of Mycophenolate Mofetil Hydrochloride, Anda #211374 (REMS)FDA Approved DrugsApproval Date: 07/29/2026; Drug Name: Mycophenolate Mofetil Hydrochloride, Anda #211374; Active Ingredients: MYCOPHENOLATE MOFETIL HYDROCHLORIDE; Company: Amneal; Submission Status: Approval; Submission Classification: REMS; Application Number: 211374
- 3mo agoAMRXApproval of Mycophenolate Mofetil, Anda #090606 (REMS)FDA Approved DrugsApproval Date: 07/29/2026; Drug Name: Mycophenolate Mofetil, Anda #090606; Active Ingredients: MYCOPHENOLATE MOFETIL; Company: Amneal; Submission Status: Approval; Submission Classification: REMS; Application Number: 090606
- 3mo agoAMRXAmneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and PresentationsGlobeNewswireApproval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolioPortfolio now positioned to address the
- 4mo agoAMRXZambon and Amneal Announce Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor FluctuationsGlobeNewswirePositive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more "Good ON" time with fewer daily doses compared with immediate-release levodopa/carbidopaHopledo® is
- 4mo agoAMRXREGNFDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug ManufacturingFDA Press ReleasesToday, the U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.The FDA launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 1 ...
- 4mo agoAMRXApproval of Iohexol, Anda #217737 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 06/25/2026; Drug Name: Iohexol, Anda #217737; Active Ingredients: IOHEXOL; Company: Amneal; Submission Status: Approval; Submission Classification: Manufacturing (CMC); Application Number: 217737
- 4mo agoAMRXApproval of Methylprednisolone Sodium Succinate, Anda #207549 (Labeling)FDA Approved DrugsApproval Date: 06/25/2026; Drug Name: Methylprednisolone Sodium Succinate, Anda #207549; Active Ingredients: METHYLPREDNISOLONE SODIUM SUCCINATE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 207549
- 4mo agoAMRXApproval of Buprenorphine, Anda #211586 (REMS)FDA Approved DrugsApproval Date: 06/18/2026; Drug Name: Buprenorphine, Anda #211586; Active Ingredients: BUPRENORPHINE; Company: Amneal; Submission Status: Approval; Submission Classification: REMS; Application Number: 211586
- 5mo agoAMRXDispensary of Hope Launches "Hope Alliance" Campaign with Support from Amneal PharmaceuticalsPR NewswireDispensary of Hope announced the launch of its national "Hope Alliance" campaign this year, a strategic initiative designed to expand access to...
- 5mo agoAMRXApproval of Macitentan, Anda #211000FDA Approved DrugsApproval Date: 06/08/2026; Drug Name: Macitentan, Anda #211000; Active Ingredients: MACITENTAN; Company: Amneal; Submission Status: Approval; Application Number: 211000
- 5mo agoAMRXAmneal Announces Full Study Population Interim Phase 4 ELEVATE-PD Results, Reinforcing Previously Reported Benefits of CREXONT® in Parkinson's DiseaseGlobeNewswirePhase 4 ELEVATE-PD interim data from the entire study population (n=214) continue to show clinically meaningful, consistent benefits of CREXONT across all prior treatment groupsSubstantial increases in daily "Good On"
- 5mo agoAMRXAmneal Announces U.S. FDA Approval of Romidepsin Injection SolutionGlobeNewswireReady-to-use romidepsin formulation; offers a more convenient alternative to lyophilized powder requiring reconstitutionCompetitive Generic Therapy approval provides 180 days of market exclusivity and further expands
- 5mo agoAMRXApproval of Romidepsin, Anda #219099FDA Approved DrugsApproval Date: 06/02/2026; Drug Name: Romidepsin, Anda #219099; Active Ingredients: ROMIDEPSIN; Company: Amneal; Submission Status: Approval; Application Number: 219099
- 5mo agoAMRXAmneal to Participate in Goldman Sachs 47th Annual Global Healthcare Conference 2026GlobeNewswireBRIDGEWATER, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), today announced that Chirag Patel, Co-Chief Executive and President, will participate and
- 5mo agoAMRXApproval of Phytonadione, Anda #217734FDA Approved DrugsApproval Date: 06/01/2026; Drug Name: Phytonadione, Anda #217734; Active Ingredients: PHYTONADIONE; Company: Amneal; Submission Status: Approval; Application Number: 217734
- 6mo agoAMRXApproval of Tretinoin, Anda #217497FDA Approved DrugsApproval Date: 05/14/2026; Drug Name: Tretinoin, Anda #217497; Active Ingredients: TRETINOIN; Company: Amneal; Submission Status: Approval; Application Number: 217497
- 6mo agoAMRXApproval of Pyridostigmine Bromide, Nda #217604 (Labeling)FDA Approved DrugsApproval Date: 05/12/2026; Drug Name: Pyridostigmine Bromide, Nda #217604; Active Ingredients: PYRIDOSTIGMINE BROMIDE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 217604
- 6mo agoAMRXAmneal Reports First Quarter 2026 Financial ResultsGlobeNewswire‒ Q1 2026 Net Revenue of $723 million; GAAP Net Income of $62 million; Diluted Income per Share of $0.19 ‒‒ Adjusted EBITDA of $202 million; Adjusted Diluted EPS of $0.27 ‒‒ No Change from Preliminary Results Previously
- 6mo agoAMRXApproval of Leuprolide Acetate, Anda #215336 (Labeling)FDA Approved DrugsApproval Date: 05/06/2026; Drug Name: Leuprolide Acetate, Anda #215336; Active Ingredients: LEUPROLIDE ACETATE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 215336
- 6mo agoAMRXApproval of Lenalidomide, Anda #216213 (REMS)FDA Approved DrugsApproval Date: 04/27/2026; Drug Name: Lenalidomide, Anda #216213; Active Ingredients: LENALIDOMIDE; Company: Amneal; Submission Status: Approval; Submission Classification: REMS; Application Number: 216213
- 6mo agoAMRXKashiv BioSciences Agrees to Be Acquired by Amneal Pharmaceuticals to Create a Fully Integrated Global Biosimilar LeaderBusiness WireThe proposed combination will create a differentiated global biosimilars platform that leverages Kashiv BioSciences' development and manufacturing capabilities with Amneal Pharmaceuticals' commercial
- 6mo agoAMRXAmneal Agrees to Acquire Kashiv BioSciences to Create Global Biosimilar Leader; Reports Strong Preliminary First Quarter 2026 Financial Results and Raises FY2026 Standalone GuidanceGlobeNewswire– Acquisition Positions Amneal to Capitalize on $300B+ Global Biologics LOE Opportunity – – Transaction Accelerates Growth Profile and Diversification – – Preliminary Q1 Results Reflect Continued Growth and Raising
- 6mo agoAMRXAmneal Announces Additional Positive Interim Phase 4 ELEVATE-PD Results with CREXONT® for Parkinson's Disease, Including Over 3 More Hours of Daily "Good On" Time When Switching from RYTARY®GlobeNewswirePhase 4 ELEVATE-PD interim data (n=111) demonstrated clinically meaningful, consistent benefits of CREXONT across all prior treatment groupsDemonstrated substantial increases in daily "Good On" time, reductions in "Off"
- 7mo agoAMRXAmneal Launches First Two Respiratory Metered-Dose Inhalation Products in the U.S.GlobeNewswireLaunch of albuterol sulfate inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol BRIDGEWATER, N.J., April 14, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company")
- 7mo agoAMRXAmneal Launches Bimatoprost Ophthalmic Solution, 0.01%GlobeNewswireBRIDGEWATER, N.J., April 09, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") today announced the launch of bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). The product
- 7mo agoAMRXAmneal to Report First Quarter 2026 Results on May 1, 2026GlobeNewswireBRIDGEWATER, N.J., April 07, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), today announced that the Company will release its first quarter 2026 financial results on
- 7mo agoAMRXAmneal Announces $2 Million Donation to Support Patient Access to Essential Medicines During Parkinson's Awareness MonthGlobeNewswireBRIDGEWATER, N.J., April 07, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ:AMRX) today announced donations totaling $2 million to multiple patient assistance foundations
- 7mo agoAMRXApproval of Brexpiprazole, Anda #213562 (Labeling)FDA Approved DrugsApproval Date: 04/01/2026; Drug Name: Brexpiprazole, Anda #213562; Active Ingredients: BREXPIPRAZOLE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 213562
- 8mo agoAMRXApproval of Nicardipine Hydrochloride, Anda #215406 (Labeling)FDA Approved DrugsApproval Date: 03/06/2026; Drug Name: Nicardipine Hydrochloride, Anda #215406; Active Ingredients: NICARDIPINE HYDROCHLORIDE; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 215406
- 8mo agoAMRXAmneal to Participate in Upcoming Investor ConferenceGlobeNewswireBRIDGEWATER, N.J., March 05, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) today announced that Chirag Patel, Co-Chief Executive and President, will participate in a fireside chat at the following
- 8mo agoAMRXApproval of Sodium Acetate, Anda #218469 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 03/02/2026; Drug Name: Sodium Acetate, Anda #218469; Active Ingredients: SODIUM ACETATE; Company: Amneal; Submission Status: Approval; Submission Classification: Manufacturing (CMC); Application Number: 218469
- 8mo agoAMRXAmneal 4Q 2025 Earnings Call - AMNEAL PHARMACEUTICALS INCEarnings Call TranscriptsGood morning, and welcome to the AMNEAL Pharmaceuticals Fourth Quarter and Full Year 2025 Earnings Call. I'll now hand the call over to AMNEA's Head of Investor Relations, Tony DiMaio. Go ahead, please, sir. Good morning
- 8mo agoAMRXAmneal Reports Fourth Quarter and Full Year 2025 Financial ResultsGlobeNewswire‒ Full Year 2025 Performance Met or Exceeded All Guidance Metrics and 2026 Reflects Another Year of Growth – ‒ Q4 2025 Net Revenue of $814 million; GAAP Net Income of $35 million; Diluted Income per Share of $0.11 ‒ ‒
- 8mo agoAMRXApproval of Mycophenolate Mofetil, Anda #214871 (Labeling)FDA Approved DrugsApproval Date: 02/23/2026; Drug Name: Mycophenolate Mofetil, Anda #214871; Active Ingredients: MYCOPHENOLATE MOFETIL; Company: Amneal; Submission Status: Approval; Submission Classification: Labeling; Application Number: 214871
- 9mo agoAMRXPBHVKTXPODDAccessible Health Platforms Gain Scale Across $6T Health and Wellness MarketPR NewswireEquity-Insider.com News Commentary – The global health and wellness sector is entering 2026 on a trajectory toward $6 trillion in annual consumer...
- 9mo agoAMRXAmneal Pharmaceuticals Added to S&P SmallCap 600® IndexGlobeNewswireBRIDGEWATER, N.J., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company") today announced that it has been added to the S&P SmallCap 600® Index. The inclusion