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Alnylam Receives Approval in Europe for AMVUTTRA (vutrisiran) for the Treatment of Hereditary Transthyretin-mediated (hATTR) Amyloidosis in Adult Patients with Stage 1 or Stage 2 Polyneuropathy

The EC approval is based on positive 18-month results from the HELIOS-A Phase 3 study, where AMVUTTRA significantly improved the signs and symptoms of hATTR amyloidosis, with more than 50 percent of patients experiencing halting or reversal of their polyneuropathy manifestations.
France General United Kingdom Kasha Witkos David Adams Subcutaneous Administration Once Every Three Months Head Of The Neurology Department

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BioNTech SE: Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY Original/Omicron BA.4-5 and COMIRNATY Original/Omicron BA.1 bivalent
United States United Kingdom Sylke Maas Fosun Pharma Pfizer Inc Nasdaq European Commission

CHMP adopts positive opinion for Mycapssa for the treatment of Acromegaly

16.09.2022 - CHMP adopts positive opinion for Mycapssa for the treatment of Acromegaly Positive opinion based on MPOWERED Phase 3 trial DUBLIN, Ireland, and Boston MA, September 16, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical ... Seite 1
United States European Union European Medicines Agency European Commission Committee For Medicinal Products Human Use European Medicines

ADC Therapeutics SA: ADC Therapeutics and Sobi Announce ZYNLONTA (loncastuximab tesirine) Receives Positive CHMP Opinion in Europe for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Approval decision expected in 4Q 2022 ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European
United Kingdom United States New Jersey City Of Amanda Loshbaugh Lausanne Biop

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