Novartis, Genentech file suit alleging illegal importation of prescription drug

Novartis and Genentech are suing a U.S. company and a Canadian pharmacy over the importation of a Canadian version of their ...

OS Therapies Initiates FDA BLA Filing for OST-HER2 to Prevent or Delay Recurrent Pulmonary Metastatic Osteosarcoma

Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data ...

FDA to offer bonus payments to staffers who complete speedy drug reviews

The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete ...

Shares of Bala Cynwyd biotech soar as FDA filing nears for rare disease drug

The Bala Cynwyd company received breakthrough designation from the Food and Drug Administration.
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FDA proposes system to approve customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...

US FDA approves Eton Pharma's hormonal disorder drug

Food ‌and Drug ​Administration approved on Wednesday Eton ‌Pharmaceuticals' ⁠oral liquid therapy ⁠for a ​rare ​childhood ...

Vanda Pharmaceuticals Inc.: Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular ...

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

CDSCO eases drug testing approvals, new fast-track system from June 1, 2026

CDSCO to issue instant NOCs for drug testing from June 1, 2026, speeding up approvals while retaining technical scrutiny at ...

Romanian court rejects Wiz Khalifa's appeal against 9-month jail sentence for drug possession

A Romanian court on Thursday rejected an appeal by American rapper Wiz Khalifa to annul his nine-month jail sentence handed ...