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Regulatory update
Regulatory update
Regulatory update
Takeda Receives European Commission Approval for ADZYNMA®▼ (Recombinant ADAMTS13) as the First and Only Recombinant ADAMTS13 Replacement Therapy for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
pharmaquotient.com
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7 September 2024
Regulatory update
European Commission approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk
Regulatory update
Emergent BioSolutions’ ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa &...
Regulatory update
Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria (PNH)
Regulatory update
European Commission approves RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure...
generic
Sandoz Received EU Approval of Tyruko® (natalizumab) for multiple sclerosis in Europe
pharmaquotient.com
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26 September 2023
0
Regulatory update
Abbvie Announces EU Approval of Tepkinly (epcoritamab) for Adults with R/R Diffuse Large B-cell Lymphoma
pharmaquotient.com
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25 September 2023
0
Regulatory update
Janssen files sNDA Seeking full Approval of BALVERSA® (erdafitinib) Locally Advanced or Metastatic Urothelial Carcinoma
pharmaquotient.com
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29 August 2023
0
generic
FDA Approves Biosimilar Tyruko® for the Treatment of Relapsing Forms of Multiple Sclerosis
pharmaquotient.com
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25 August 2023
0
Regulatory update
Janssen Announced EU approval of TECVAYLI® with Reduced Dosing Frequency
pharmaquotient.com
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18 August 2023
0
China
AstraZeneca announced Forxiga China Approval in Symptomatic Heart Failure Patients
pharmaquotient.com
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18 August 2023
0
Regulatory update
Abbvie Announces EU Approval of AQUIPTA®(atogepant)
pharmaquotient.com
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17 August 2023
0
Regulatory update
JNJ Expands Cancer Portfolio with TALVEY Approval
pharmaquotient.com
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10 August 2023
1
Update
US FDA Approves Zurzuvae For Postpartum Depression
pharmaquotient.com
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4 August 2023
1
Regulatory update
U.S. FDA Approves Merck’s ERVEBO®
pharmaquotient.com
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3 August 2023
0
Regulatory update
Daiichi’s mRNA COVID-19 Booster Vaccine Approved in Japan
pharmaquotient.com
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2 August 2023
0
Regulatory update
China’s NMPA Accepts Astellas’ Biologics License Application for Zolbetuximab
pharmaquotient.com
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1 August 2023
0
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Takeda Receives European Commission Approval for ADZYNMA®▼ (Recombinant ADAMTS13) as the First and Only Recombinant ADAMTS13 Replacement Therapy for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
7 September 2024