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Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)
22 Oct 2024 11:00 GMT
Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis
The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single …
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Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)
22 Oct 2024 11:00 GMT
Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis
The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single …
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European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
15 Aug 2024 08:30 GMT
The approvals process is anticipated to be completed in the third quarter of 2025 REYKJAVIK, Iceland and LONDON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of …
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Alvotech Announces Positive Topline Results from Confirmatory Patient Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
02 Jul 2024 13:00 GMT
Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab)
Two additional studies comparing the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively, have also met …
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NRx Pharmaceuticals Eyes First Commercial Revenue in 2024, Announces Breakthroughs in Bi-Annual Milestones: NASDAQ NRXP
09 May 2024 12:30 GMT
NRx Pharmaceuticals Sets Sights on Debut Commercial Revenue in 2024, Unveils Innovative Advances in Bi-Annual Progress Report: (Nasdaq: NRXP)
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)
WILMINGTON, DELAWARE, UNITED STATES, May 9, 2024 /EINPresswire.com …
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Oral Antidepressants for Reduction in Suicidality Could Deliver New Standard of Care for Bipolar Depression: NASDAQ NRXP
30 Apr 2024 15:07 GMT
Revolutionizing Bipolar Depression Treatment: The Potential of Oral Antidepressants: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)
WILMINGTON, DELAWARE, UNITED STATES, April 30, 2024 /EINPresswire.com/ -- …
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New Data on Infection Avoidance and Development of pH Neutral Ketamine, for Intravenous & Subcutaneous Use NASDAQ: NRXP
17 Apr 2024 14:57 GMT
NRx Pharmaceuticals Unveils New Data on Infection Avoidance and pH Neutral Ketamine Development: (Nasdaq: NRXP)
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)
WILMINGTON, DELAWARE, UNITED STATES , April 17, 2024 /EINPresswire.com/ -- New Data on …
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Strong Q4 Results and Milestones Announced Including Approved Stock Dividend & 8 Million More in Capital: (Nasdaq: NRXP)
01 Apr 2024 19:03 GMT
NRx Pharmaceuticals (Nasdaq: NRXP) Reports Strong Q4 Results and Milestones Achieved
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)
WILMINGTON, DELAWARE, UNITED STATES , April 1, 2024 /EINPresswire.com/ -- Strong Q4 Results and Milestones Announced …
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Alvotech Provides Regulatory Update on AVT02 Biologics License Application
14 Apr 2023 00:45 GMT
REYKJAVIK, Iceland, April 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug …
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Alvotech and STADA Broaden Access to Hukyndra® adalimumab biosimilar in Europe
07 Dec 2022 09:00 GMT
Hukyndra® (adalimumab) launches in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia, increasing availability of high-concentration, citrate-free adalimumab in Europe Follows initial introduction of Hukyndra in nine countries: …
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