Jump in fees for new drug applications expected An industry expert, who works in one of the top pharma companies of India, ...

The authorised ANDA is a therapeutic equivalent of the reference-listed drug (RLD), Corlanor tablets, in the same 5 mg and ...

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 ("GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

Johnson & Johnson sued the U.S. Health and Human Services Department on Tuesday, accusing the agency of blocking its plan to ...

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

While A.I. promises breakthroughs, industry leaders warn that transparency and patient safety must remain front and center.

Aerobic exercise has been linked with Parkinson's disease progression and risk. ( Washington Post) Air purifiers in residential aged-care facilities did not reduce the incidence of acute respiratory ...

The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

Novartis is paying $150 million for a closer look at Schrödinger’s catalog of programs. The Big Pharma will work with Schrödinger to advance some of the computing-enabled R&D shop’s discovery programs ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...