Pharmaceutical

FDA Accepts Arcutis’ Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6

FDA has set a PDUFA target action date of July 07, 2024Atopic dermatitis affects approximately 16.5 million adults and 9.6...

Eagle Pharmaceuticals Announces Receipt of Notification of Deficiency from Nasdaq Regarding Requirement to Timely File Quarterly Report on Form 10-Q

WOODCLIFF LAKE, N.J., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (the “Company”) today announced that it...

SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes

First subject has been dosed in the first-in-man Phase 1 clinical study of SAB-142, the first fully-human anti-thymocyte immunoglobulin (ATG)...

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina

RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the National Administration...

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

SUNNYVALE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. , a developer of cellular and cell-derived therapeutics for the...

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary...

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary...

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