Medscape22h
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
JD Supra1d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will ...
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FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
FDA Approves First New Non-Opiod Painkiller in Decades
Journavx is designed to eliminate the risks of addiction and overdose associated with medications like Vicodin and OxyContin.
Business Wire13d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
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Tonix Pharma Stock’s Retail Chatter Explodes After FDA Nod For New Drug Application
The spike followed news that the U.S. Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA ... expediting the review process due to its potential to address ...
Cure Today27d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for ... Breakthrough Therapy Designation: a process that speeds up the development and review of ...
Business Wire1mon
Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS ...
has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor ...
Yahoo Finance14d
Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia
January 17, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application ...