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Trials & Approvals Biogen
FDA Pushes Biogen’s ALS Drug Approval Date Back Three Months
2022-10-18
Funding FDA
Nineteen Grants and Two Contracts Grab $38 Million In Support From the FDA
2022-10-17
Trials & Approvals Biomarin Pharmaceuticals
FDA Accepts Resubmission of BioMarin’s Gene Therapy Two Years After Rejection
2022-10-13
COVID-19 Pfizer/BioNTech
Pfizer/BioNTech’s Omicron Booster Snags Another FDA Emergency Use Authorization
2022-10-12
Trials & Approvals Albireo
Albireo Signals To Apply For FDA Approval After Trial Win
2022-10-12
Trials & Approvals Breast Cancer
Action Date Set for Gilead Sciences’ HR+/HER2- breast cancer sBLA
2022-10-11
Trials & Approvals GSK
FDA Expands Use Of GSK’s Pertussis Vaccine To Cover Pregnancy
2022-10-11
Trials & Approvals Hereditary Angioedema
FDA Accepts and Boosts sBLA for Takeda’s HAE Treatment for Pediatric Patients
2022-10-06
Trials & Approvals Duchenne Muscular Dystrophy-dmd
Sarepta Submits BLA for First-Ever Duchenne Muscular Dystrophy Gene Therapy
2022-10-03
Trials & Approvals Colorectal Cancer
Priority Review of Seagen’s Colorectal Cancer Treatment Wins FDA Acceptance
2022-09-19
Trials & Approvals FDA
Otsuka and Lundbeck’s Treatment for Schizophrenia and Bipolar I NDA Accepted by the FDA
2022-09-13
Special Monkeypox
Monkeypox Update: New FDA Testing Guidelines as the US Passes 20,000 Cases
2022-09-08
Trials & Approvals Pfizer
Pfizer’s Potential GBS Vaccines Swipes Up the FDA’s Breakthrough Therapy Designation
2022-09-07
Trials & Approvals Orphan Drug
BioCryst’s ALK-2 Inhibitor Granted FDA Orphan Drug Status For Rare Bone Disease
2022-09-01
COVID-19 FDA
FDA Approves Both Moderna’s and Pfizer/BioNTech’s Omicron Bivalent Vaccines in One Day
2022-08-31
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