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09.12.2025
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Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals
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BRIDGEWATER, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical t...
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© Globe Newswire
05.12.2025
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Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease
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BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the Parkinson’s Study Group (PSG) Annual Meeting....
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© Globe Newswire
02.12.2025
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Amneal to Participate in Upcoming Investor Conferences
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BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that Chirag Patel, Co-Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will participate in following upcoming investor conferences:...
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20.10.2025
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© Globe Newswire
01.12.2025
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Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05%
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BRIDGEWATER, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The product is the generi...
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20.10.2025
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30.10.2025
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Amneal Reports Third Quarter 2025 Financial Results
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‒ Q3 2025 Net Revenue of $785 million; GAAP Net Income of $2 million; Diluted Income per Share of $0.01 ‒‒ Adjusted EBITDA of $160 million; Adjusted Diluted EPS of $0.17 ‒‒ Updated 2025 Full Year Guidance ‒...
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© Globe Newswire
27.10.2025
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Amneal Launches Brekiya® – the First and Only DHE Autoinjector for Adults with Migraine With or Without Aura and Cluster Headaches
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BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the U.S. commercial launch of Brekiya® (dihydroergotamine mesylate) injection, the first and only ready-to-use dihydroergotamine (DHE) autoinjector approved for the acute treatment of migraine with or withou...
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06.10.2025
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Kashiv Biosciences Announces Submission of Biologics License Application to U.S. FDA and Acceptance of Market Authorization Application by European Medicines Agency for ADL-018, a Proposed Biosimilar to XOLAIR® (omalizumab)
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Kashiv BioSciences, LLC, a fully-integrated biopharmaceutical company, announced that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab...
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© Globe Newswire
30.09.2025
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Amneal to Report Third Quarter 2025 Results on October 30, 2025
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BRIDGEWATER, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its third quarter 2025 financial results on Thursday, October 30, 2025, prior to market open. The Company will host an audio webcast at 8:3...
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© Globe Newswire
26.09.2025
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Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)
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Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for Amneal Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for Amneal...
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© Globe Newswire
04.09.2025
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Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension
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BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta®. The product i...
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© Globe Newswire
21.07.2025
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Amneal Reports Certain Preliminary Second Quarter 2025 Financial Results
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– Results Reflect Continued Financial Strength and Deleveraging –...
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© Globe Newswire
25.06.2025
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Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences
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Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025...
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12.06.2025
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Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension
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BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. La...
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© Globe Newswire
15.05.2025
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Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for the Acute Treatment of Migraine and Cluster Headaches in Adults
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BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with...
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02.05.2025
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Amneal Reports First Quarter 2025 Financial Results
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the first quarter ended March 31, 2025.
“Amneal delivered another strong quarter to start 2025, with broad-based growth across all three segments driven by our team’s outstanding execution. We are very pleased with the commercial uptake of CREX...
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11.04.2025
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Amneal Donates $1.5 Million to Support Patients During Parkinson’s Awareness Month
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced donations totaling $1.5 million to multiple patient assistance foundations that support individuals living with Parkinson’s disease in honor of Parkinson’s Awareness Month. These contributions underscore Amneal's ongoing com...
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08.04.2025
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Amneal to Report First Quarter 2025 Results on May 2, 2025
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Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its first quarter 2025 financial results on Friday, May 2, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET.
The financial results and live webcast will be acc...
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© BusinessWire
07.04.2025
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Amneal Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson’s Disease
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced a new analysis of the pivotal RISE-PD Phase 3 study showed that patients who successfully converted to CREXONT from immediate release (IR) carbidopa/levodopa (CD/LD) experienced statistically significant improvements in slee...
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03.04.2025
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Amneal Announces Expanded Coverage for CREXONT® (Carbidopa and Levodopa) to Enhance Access for Parkinson’s Disease Patients in the U.S.
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease...
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01.04.2025
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Amneal Launches BORUZU™, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and Shilpa Medicare Limited (“Shilpa”) today announced the U.S. launch of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product redu...
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10.03.2025
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Amneal to Participate at Upcoming Investor Conference
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) will present at the Barclays 27th Annual Global Healthcare Conference on March, 12, 2025. Chirag Patel, Co-Chief Executive Officer and President, will participate in a fireside chat at 11:00 AM ET. A live webcast of the fireside chat will be accessible on the Company's website at https://investors.amneal...
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03.03.2025
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Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia® and XGEVA®. mAbxience...
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28.02.2025
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Amneal Reports Fourth Quarter and Full Year 2024 Financial Results
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the fourth quarter and full year ended December 31, 2024.
“Amneal’s continued success in 2024 demonstrates our ability to drive sustainable growth through disciplined execution, continuous innovation, and strategic capital allocation. All thre...
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19.02.2025
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Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. Additionally, the Company has received approval from the U.S. Food an...
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29.01.2025
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Amneal to Report Fourth Quarter and Full Year 2024 Results on February 28, 2025
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Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its fourth quarter and full year 2024 financial results on Friday, February 28, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET.
The financial results and li...
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23.01.2025
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Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC®, and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis’ AFIN...
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04.12.2024
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Amneal to Participate at Upcoming Investor Conferences
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in two upcoming investor conferences.
36th Annual Piper Sandler Annual Healthcare Conference
December...
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21.11.2024
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Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for t...
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08.11.2024
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Amneal Reports Third Quarter 2024 Financial Results
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the third quarter ended September 30, 2024.
“Q3 was an excellent quarter where we continued to drive strong financial results across our diversified business and we announced three strategic actions to solidify our long-term growth. First, we l...
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21.10.2024
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Amneal Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company based in the U.S., today announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg.
PB ER 105 mg tablets are a once-...
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08.10.2024
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Amneal to Report Third Quarter 2024 Results on November 8, 2024
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Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its third quarter 2024 financial results on Friday, November 8, 2024, prior to market open. The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
The financial results and live webcast will be acces...
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01.10.2024
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Amneal and Metsera Announce Strategic Collaboration to Develop and Supply Portfolio of Next-Generation Medicines for Obesity and Metabolic Diseases
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, and Metsera, Inc. (“Metsera”), a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced that they have entered into a collaboration agreement to enable the eff...
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23.09.2024
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Amneal Launches CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has launched CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease. CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release granules and extended-release pel...
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05.09.2024
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Amneal and Shilpa Announce U.S. FDA Approval of BORUZU™, the First Ready-to-Use Version of Bortezomib for subcutaneous administration
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the co...
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20.08.2024
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Amneal Receives U.S. FDA Approval for Propofol Injectable Emulsion Single Dose Vials
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials....
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09.08.2024
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Amneal Reports Second Quarter 2024 Financial Results
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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the second quarter ended June 30, 2024.
“Amneal achieved strong revenues and adjusted EBITDA in the second quarter, and we are pleased to raise full year 2024 guidance driven by broad-based growth across our business. Amneal is a diversified a...
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