The FDA inspected the facility in April ... to "comprehensively" assess its operations. For the US import alert to be lifted, Sun Pharma must conduct an independent, retrospective assessment ...

Sun Pharma and Concert expect to complete the transaction later in the current quarter. If deuruxolitinib reaches the market, it would compete against Eli Lilly’s Olumiant, which the FDA ...

Investing.com -- Among the biggest deal dispatches this past week, Sun Pharmaceutical said it would take out Concert Pharma ... to receive payment upon final FDA premarket approval to market ...

The Food and Drug Administration said Thursday there are too many unknowns about CBD products to regulate them as foods or supplements under the agency’s current structure and called on Congress ...

The deal is the Indian drugmaker's biggest since its $3.2 billion acquisition of generic drugmaker Ranbaxy Laboratories Ltd ...

Sun Pharma’s immediate focus would be to follow Concert’s plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2023. Alopecia Areata ...

Sun Pharma will acquire all outstanding shares of Concert through a tender offer for an upfront payment of $8 per share in cash. Sun Pharmaceutical Industries, the world’s fourth-largest ...

Pharma major Glenmark ... dated 26th October 2022 informing you about the US FDA placing the Baddi (India) facility under import alert 66-40. We now wish to inform you that due to medical ...

Sun Pharma announced Thursday morning that it is acquiring Concert Pharmaceuticals for $576 million. The Indian-based pharma company will acquire all outstanding shares of the late-stage biotech that ...

The suit accuses LGM Pharma LLC, headquartered at 6400 Congress ... The company also imported ingredients from suppliers on the FDA’s Import Alerts list, which gives the agency authority to ...

If finalized, the shift would be the latest FDA move to broaden donor eligibility, with the potential to boost the U.S. blood supply. Gay rights groups have long opposed blanket restrictions on ...