Axsome Therapeutics Announced FDA Approval of AUVELITY for the Treatment of Major Depressive Disorder in Adults
Axsome Therapeutics, Inc. (NASDAQ: AXSM) today announced that the U.S.
SpringWorks Therapeutics Announces Late-Breaking Oral Presentation of Phase 3 DeFi Data at the European Society for Medical Oncology (ESMO) Congress 2022
SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that data from the
Read Why Aeglea BioTherapeutics Shares Are Skyrocketing Today?
The European Medicines Agency (EMA) has validated Aeglea BioTherapeutics Inc’s (NASDAQ:AGLE) marketing application seeking approval for pegzilarginase for the treatment of…
Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary
The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ:KRYS) Biologics License Application (BLA)…
FDA Accepts Krystal Biotech’s Filing For Genetic Skin Disorder Candidate Under Priority Review
The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ: KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB).
FDA Accepts Krystal Biotech’s Biologics License Application For Dystrophic Epidermolysis Bullosa
FDA granted Priority Review designation
PDUFA target action date is February 17, 2023
FDA stated that it is not currently planning to hold an advisory committee meeting
Caribou’s Blood Cancer Candidate Shows Response Rates Better Than Novartis,’ This Analyst Writes
Last week, Caribou Biosciences Inc (NASDAQ:CRBU) announced Q2 earnings and provided updated results from the Phase 1 ANTLER trial of the company’s…
Blueprint Medicines’ Ayvakit ‘Will Garner Approval’ Despite Questions, This Analyst Says
HC Wainwright has cut the price target on Blueprint Medicines Corporation (NASDAQ:BPMC) from $100 to $80 and reiterated the Buy rating. The analyst…
Analysts Are Bullish On 89bio’s NASH Data Slated For Early Next Year
Earlier today, 89bio Inc (NASDAQ:ETNB) concluded enrollment in ENLIVEN Phase 2b trial of pegozafermin for non-alcoholic steatohepatitis (NASH), enabling topline results in…
Biden Officials Seek To Boost Supply For Monkeypox Vaccines, Treatment
Top Biden administration officials are poised to lay out new steps to accelerate the U.S. response amid the spread of monkeypox and demand for vaccines & treatments.