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FDA OKs Perioperative Pembrolizumab in HNSCC: Findings From KEYNOTE-689
15 Jun 2025 17:54 GMT
… , 2025, as the FDA granted approval to pembrolizumab (Keytruda) … agent.
This pivotal approval stems from the KEYNOTE … and neck cancer,” he shares.
This perioperative integration of … strategies effectively.
REFERENCE:
FDA approves neoadjuvant and adjuvant …
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Stocks to Watch for June 16: Vedanta, Sun Pharma, Syngene, Nazara Technologies, ITC and more
15 Jun 2025 05:50 GMT
… | Sun Pharma confirmed a US FDA inspection at its Halol facility … US Food and Drug Administration (FDA) following a routine inspection of … on July 23 for final approval.
NTPC | The company announced the … the issue of four bonus shares for every one share held …
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AbbVie Secures FDA Approval to Expand Mavyret’s Label
15 Jun 2025 02:26 GMT
… . (NASDAQ:ENTA), for treating Hepatitis C. AbbVie Secures FDA Approval to Expand … C patients. AbbVie Inc. (NYSE:ABBV) is an international … we believe certain AI stocks offer greater upside potential … AI stock. READ NEXT: Dow 20 Stocks List: Ranked By Hedge …
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URGN SHAREHOLDERS: UroGen Pharma Ltd. Investors are Reminded of the Pending Securities Fraud Class Action – Contact BFA Law by July 28 Deadline (NASDAQ:URGN)
14 Jun 2025 11:48 GMT
… against UroGen Pharma Ltd. (NASDAQ: URGN) and certain of … submission. In truth, the FDA had previously expressed significant concerns … design and endpoints that the FDA considered appropriate.” On this … firm will seek court approval for any potential fees and …
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Proud moment for the nation, Indian Medtech Start-up rings the bell in New York, Celebrates Nasdaq Debut
14 Jun 2025 08:18 GMT
… Nasdaq MarketSite in New York City. The company’s shares … commemorating our successful uplisting to Nasdaq in April 2025. This … has commenced the regulatory approval process in the United … Union and anticipates receiving FDA approval to market and CE …
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Syngene's Bengaluru unit passes US FDA test but with VAI classification
14 Jun 2025 02:24 GMT
… US Food and Drug Administration (FDA) following a routine inspection … Report (EIR) from the USFDA vide its communication dated June … drugs and will also receive approvals for new filings.
Also Read … 11% to ₹944 crore
Shares of Syngene International Ltd ended …
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KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints
13 Jun 2025 20:19 GMT
… Pharmaceuticals, Inc. (Nasdaq: KALV) today announced … approval of sebetralstat. We are continuing to work closely with the FDA … multiple regulatory applications seeking approval of sebetralstat as … and to obtain regulatory approvals for sebetralstat and other …
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UroGen Soars On Price Target Upgrade On Heels Of FDA Approval For Cancer Medicine: Retail Sees Stock Touching $20
13 Jun 2025 19:24 GMT
… its Zusduri medication.
The FDA approved Zusduri for adults with … ‘Buy’ rating on the shares.
The new price target implies … 11.08 on Thursday.
The FDA approval for Zusduri, a day ahead … ending hopes for approval as the FDA considers independent advice from …
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UroGen Pharma Ltd. (URGN) Faces Securities Class Action Amid FDA’s Briefing Document and Subsequent ODAC Vote Against UGN-102– Hagens Berman
13 Jun 2025 16:19 GMT
… price of their shares in UroGen Pharma Ltd. (NASDAQ: URGN) crash … the FDA that ENVISION could support UGN-102’s approval despite … document reflected that the FDA repeatedly advised UroGen to … its communications with the FDA, particularly about the agency …
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InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
13 Jun 2025 13:00 GMT
… ) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard … this year, subject to FDA approval, enabling greater scale as … and regulation, including potential FDA approval and potential U.S. … obtain and maintain regulatory approvals for our products; our …
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