FDA to Speed Biosimilar Approvals in Push to Cut Drug Costs (1)

The FDA is planning to speed approvals of highly similar copies of expensive biologic drugs, the latest effort in President ...
TipRanks on MSN

BioNxt Launches 15-day Sublingual Cladribine Dosing Optimization Study in Preparation for Human Bioequivalence Study

VANCOUVER, BC / ACCESS Newswire / October 21, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug ...
The Pharma Letter

Positive pivotal bioequivalence study of Relief’s RLF-OD032

Swiss biopharma Relief Therapeutics today announced positive results from its pivotal bioequivalence clinical study ...
TipRanks on MSN

BioNxt Enters the Final Stretch Before Human Trials for Next-Generation MS Drug

New York, USA, October 22nd, 2025, FinanceWire BioNxt Solutions Inc. (CSE:BNXT) (OTCQB:BNXTF) (FSE:BXT), a bioscience company ...
JD Supra

FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product specific guidances to align with ICH M13A BE ...

The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...
Business Wire

Alpha Cognition Announces Positive Topline Results from Bioequivalence Study with ALPHA-1062 in Development for Alzheimer’s Disease

VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha Cognition,” or the “Company”), a biopharmaceutical company committed to developing novel ...
PharmiWeb

Relief Therapeutics Announces Positive Results from Pivotal Bioequivalence Study of RLF-OD032

RLF-OD032 demonstrated bioequivalence to KUVAN® PowderStudy results support planned 505(b)(2) NDA submission in early 2026 GENEVA, SWITZERLAND / ACCESS Newswire / October 29, 2025 / RELIEF ...
Nature

Bioequivalence Studies and Adaptive Design Methods

Bioequivalence studies are an essential component in the development and approval of generic pharmaceutical products, ensuring that they perform similarly to their reference counterparts. These ...
Pharmabiz

A section of industry opposes CDSCO’s move to open consultation on cost of regulatory compliance for new drug

Shardul Nautiyal, Mumbai Wednesday, October 15, 2025, 08:00 Hrs [IST] ...
JD Supra

FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
Nasdaq

Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, and Planned Commercial Formulations of Roluperidone for Treatment of Negative ...

WALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central ...