Latest News for: chmp

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Accord Healthcare Receives Positive CHMP Opinion for Denosumab, Osvyrti®, and Jubereq®

PR Newswire 02 Apr 2025
The CHMP has issued a positive opinion for Denosumab, to be marketed as Osvyrti® and Jubereq® ... "At Accord, we are dedicated to transforming patients' lives, and the recent CHMP approval of these vital medicines is a significant milestone.
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Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of Pediatric Myopia

Business Wire 01 Apr 2025
(www.sydnexis.com), a pre-commercial stage biopharmaceutical company, today announced that the ...
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BeiGene Receives Positive CHMP Opinion for TEVIMBRA� as a First-Line Treatment for Extensive-Stage Small Cell ...

Business Wire 31 Mar 2025
688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today ...
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Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications

PR Newswire 31 Mar 2025
The CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union ... The CHMP positive opinion is supported by positive results from the Phase 3 CheckMate -67T trial.
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Santen Receives Positive CHMP Opinion in Europe for Ryjunea🄬 for slowing the progression of paediatric myopia (Santen Pharmaceutical Co Ltd)

Public Technologies 31 Mar 2025
) Santen Receives Positive CHMP Opinion in Europe for Ryjunea for slowing the progression of paediatric myopia ... for Human Use (CHMP) has granted a positive opinion for Ryjunea (development code.
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Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma (Form 6-K) (AstraZeneca plc)

Public Technologies 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma ... The Committee for Medicinal Products for Human Use (CHMP) ...
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Lilly’s statement about the CHMP opinion issued for donanemab (Eli Lilly and Company)

Public Technologies 28 Mar 2025
). The text version of this document is not available ... Disclaimer ... (noodl. 123324506) .
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Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo� (nivolumab) and ...

Business Wire 28 Mar 2025
PRINCETON, N.J.--(BUSINESS WIRE)---- $BMY #CHMP--BMS Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo and Chemotherapy Followed by Surgery and Adjuvant Opdivo.... .
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