Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following ...

Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of ...

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention ...
BioSpace

FDA accepts BridgeBio’s application for potential first limb-girdle muscular dystrophy drug

The FDA has set a target action date of November 27 for BBP-418’s new drug application in limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) and is not planning to hold an advisory committee ...

RFK Jr.’s Muddled Claims on Drug Approval Speed

The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...
MarketBeat on MSN

Alvotech plans June FDA resubmissions, sees biosimilar approvals by year-end

Teva Pharmaceuticals Stock: Unlock Value in This Generic Drug Gem Alvotech (NASDAQ:ALVO) Chief Strategy Officer Balaji Prasad ...
Nextgov

FDA launches updated AI and consolidated data platform

The Food and Drug Administration’s flagship internal AI tool, Elsa, is being integrated with the data platform so that staff can accomplish work more easily. FDA Data Governance IT Modernization The ...
RAPS

FDA cites firms for CGMP violations, failure to submit PMA application

FDA investigator badges on display at FDA's White Oak campus (credit: Ferdous Al-Faruque) The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated ...
FiercePharma

FDA expectations create potential friction in new Form 483 response guidance

Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when ...
Becker's Hospital Review

Pharma company withdraws FDA application amid White House autism treatment push

GSK, a biopharmaceutical company, has withdrawn its application to the FDA for leucovorin calcium tablets, months after the White House promoted the drug as a potential treatment for autism-related ...
BioSpace

Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs

BOSTON, March 30, 2026 (GLOBE NEWSWIRE)-- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, ...
JD Supra

FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance is intended for ...