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Trials & Approvals Bipolar Disorder
Alkermes Overcomes Regulatory Setbacks to Snag FDA Approval for Schizophrenia Drug
2021-06-01
Trials & Approvals Cholangiocarcinoma
FDA Okays Second FGFR Inhibitor for Cholangiocarcinoma, Approves FMI’s CGP Test as Companion Diagnostic
2021-05-31
Trials & Approvals KRAS
We Have a Winner! Amgen Grabs First FDA Nod in the Race for Undruggable KRAS
2021-05-30
COVID-19 Antibody
FDA Grants Emergency Use Authorization to Third COVID-19 Antibody Therapy
2021-05-27
Trials & Approvals CTI-1601
Larimar Drops $95M Private Financing Plans after FDA Orders Clinical Hold on Rare Disease Therapy
2021-05-27
Trials & Approvals EGFR
FDA Approves First Targeted Therapy for EGFR Lung Cancer with Exon 20 Mutations
2021-05-24
Trials & Approvals Gene Therapy
Sarepta to Begin Phase 3 Rivalry with Pfizer after its DMD Gene Therapy Registers Encouraging Data
2021-05-21
COVID-19 Vaccine
SK Bioscience Receives EU-GMP Certification for COVID-19 Vaccine Production Plant, Making it Korea’s First
2021-05-18
COVID-19 Vaccine
Sanofi, GSK Report Positive Trial Data for COVID-19 Vaccine
2021-05-18
COVID-19 mRNA Vaccine
FDA Authorizes Pfizer/BioNTech’s COVID-19 Vaccine for 12 to 15 Year Olds
2021-05-11
COVID-19 2-deoxy-D-glucose
India Approves Oral COVID-19 Drug for Emergency Use to Abate Oxygen Crisis
2021-05-09
Trials & Approvals Avrobio
Full Approval of Treatment Standard Forces Avrobio to Adjust Fabry Disease Therapy Plans
2021-05-04
Trials & Approvals Type 2 Diabetes
FDA Greenlights AstraZeneca’s Blockbuster Drug for Chronic Kidney Disease
2021-05-02
Trials & Approvals Rare Disease
FDA Rejects Protalix’s Enzyme Replacement Therapy for Rare Genetic Disease
2021-04-29
Trials & Approvals Cancer
GSK’s Oncology Drug Acquired from Tesaro Notches Accelerated Approval for Endometrial Cancer
2021-04-25
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