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WASHINGTON, D.C. — The U.S. Food and Drug Administration granted accelerated approval to Replimune Inc.’s Tudriqev in combination with nivolumab for adults with unresectable advanced melanoma that progressed after PD-1-based …
FDA Clears Viral Therapy for Treatment-Resistant Melanoma Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) began its rolling U.S. application for QTORIN rapamycin during the second quarter as higher clinical, manufacturing and regulatory spending more than doubled …
Palvella Advances FDA Filing as Drug Spending Lifts Loss Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Takeda Pharmaceuticals America’s Orzeyful tablets for adults with narcolepsy type 1, making it the first treatment cleared to address the …
FDA Approves First Orexin-Targeting Narcolepsy Type 1 Drug Read More
WAYNE, PA — Teleflex Inc. (NYSE: TFX) has secured U.S. Food and Drug Administration approval for the first licensed freeze-dried plasma product in the country, potentially expanding access to plasma …
Teleflex Wins FDA Approval for Shelf-Stable Plasma Product Read More
PHILADELPHIA, PA — Proscia received a new U.S. Food and Drug Administration 510(k) clearance for its Concentriq AP-Dx digital pathology platform, expanding scanner compatibility and giving the company a regulatory …
Proscia Wins FDA Clearance to Expand Digital Pathology Platform Read More
WEST CONSHOHOCKEN, PA — The U.S. Food and Drug Administration has listed a patent covering HemiClor, a 12.5-milligram chlorthalidone tablet for treating hypertension, in its Orange Book, extending intellectual property …
FDA Lists HemiClor Patent, Extending Market Protection to 2045 Read More
MALVERN, PA — The U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to Ocugen Inc.’s experimental OCU410 gene therapy for geographic atrophy, giving the blindness treatment access …
FDA Gives Ocugen Gene Therapy Expedited Regulatory Status Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. received FDA clearance to begin a registrational Phase 2b trial of its SkinJect microneedle patch in patients with Gorlin Syndrome, advancing the treatment toward …
ICYMI: FDA Clears Medicus to Begin Gorlin Syndrome SkinJect Trial Read More
WASHINGTON, D.C. — The Food and Drug Administration licensed the first freeze-dried plasma product for U.S. use last week, creating a room-temperature option for treating adult patients when conventional plasma …
FDA Clears First Freeze-Dried Plasma for Emergency Use Read More WILMINGTON, DE — Inhibikase Therapeutics Inc. (Nasdaq: IKT) has received U.S. Food and Drug Administration Orphan Drug Designation for its lead pulmonary arterial hypertension drug candidate, a regulatory milestone that …
Inhibikase Wins FDA Orphan Status for PAH Drug Candidate Read More