US FDA grants breakthrough therapy designation to Synageva's s...

The decades-old fight over genetically modified food has reached a fever pitch in Washington. The Obama administration and Congress are weighing the safety of technological advances that seem ripped from science fiction, including salmon that can ...

Smarting from its $500 million fine from the US Food and Drug Administration (FDA) last week, Japan's Daiichi Sankyo, the current promoter of Ranbaxy Laboratories, indicated on Wednesday that it might take legal recourse against the Indian generic ...

(Reuters) - The U.S. Food and Drug Administration imposed an "import alert" on a plant operated by generic drugmaker Wockhardt Ltd, sending its shares down 20 percent on Thursday to their lowest level in seven months. An "import alert", effectively a ban, ...

The Maharashtra Food and Drug Administration (FDA) has decided to crack down on the cartelisation of the medicine and drug industry by asking companies to terminate their memorandums of understanding (MoU) in order to be able to manufacture drugs that are in ...

Today Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY (peginterferon beta-1a), the company's pegylated subcutaneous injectable ...

The US Food and Drug Administration (FDA) has now issued a draft guideline on expanded access to investigational new drugs (IND) for treatment use in a 21 questions and answers format. The regulatory authority is now seeking the responses on this by ...

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 ...

May 15 (Reuters) - The U.S. Food and Drug Administration has approved Johnson & Johnson's drug Simponi for patients with moderate to severe ulcerative colitis, an inflammatory disease affecting the colon. Simponi is already approved to treat ...

Glenmark Generics Limited has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) with a Paragraph IV Certification, to sell generic version of Azelaic Acid, gel 15% topical.