Us Drug Regulator

Biocon surged after Mylan got a nod for breast cancer tablets, while Alkem Labs rose due to a nod for an ointment to treat ventricular tachycardia.

Nomura upbeat on Dr Reddy's over 1-3 years; maintains buy call

Research firm cites launch of complex products, higher approvals to bode well for the stock over 1-3 year horizon. However, in the near term, it expects earnings to be hit due to litigation loss and delay in resolution of US FDA’s warning letters, among others.

Wockhardt tanks 7% on FDA‘s warning letter to US arm

Morton Grove Pharmaceuticals, a subsidiary of the firm, received a warning letter from the US drug regulator. The move is a blow to the company as it struggles with regulatory non-compliance.

USFDA to review Biocon-Mylan's biosimilar drug for breast cancer

Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.

Mkt consolidating, may see 3-5% upside/downside: Nipun Mehta

Nipun Mehta, Founder & CEO, Blue Ocean Capital Advisors is of the view that market is currently consolidatng and it is possible for the Indian benchmark indices to see a 3-5 percent upmove or down move.

Sun Pharma down 6% on surprise audit by USFDA at Halol unit

Sources say Sun Pharma was taken by surprise when a team of 5 inspectos of United States Food and Drug Administration (US FDA) walked in on Monday morning for inspection that is still ongoing.

Ranbaxy gets USFDA clean chit for Ohm Laboratories

Drug maker Ranbaxy received a clean chit from the US Food and Drug Administration (USFDA) for its New-Jersey based Ohm Laboratories.