QRx to face FDA panel in July

Two more compounding pharmacies have recalled some of their sterile drugs from the market after the FDA expressed concern about manufacturing hygiene and

Elixir Medical Corporation, a developer of products that combine medical devices with pharmaceuticals, has received the FDA approval to initiate patient enrollment in the EXCELLA III clinical trial in the US at up to 50 institutions with conditions ...

The FDA has approved GlaxoSmithKline and Theravance's Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary ...

The Food and Drug Administration is able to do its work in part because of a symbiotic relationship with the industries it regulates. But recently that relationship has been knocked

Aurobindo Pharma has received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market tamsulosin hydrochloride capsules USP 0.4mg (ANDA 202433) and clindamycin palmitate hydrochloride for oral solution USP ...

The facility is ISO 9001 certified for Quality Management systems and ISO 14000 certified for Environment Management systems SeQuent Scientific (SeQuent) has received an US FDA approval for its API drug manufacturing facility at Mangalore, Karnataka ...

Will help in the treatment of migraine headaches in adults Glenmark Generics has been granted final abbreviated new drug approvals (ANDA's) from the United States Food and Drug Administration (US FDA) for zolmitriptan tablets, 2.5 and 5mg and ...

Thoratec Corporation, (THOR: Quote), which engages in the development, manufacture, and marketing of proprietary medical devices used for circulatory support, Friday announced that it has received approval from the U.S. Food and Drug Administration ...

The US Food and Drug Administration (FDA) has approved Tarceva (erlotinib) tablets for the initial (first-line) treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have certain epidermal growth factor receptor (EGFR) ...