AbbVie’s Epcoritamab shows progression-free survival gain in relapsed/refractory DLBCL trial

Improvements were also seen in complete response rates, duration of response, and time to next treatment

Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA

These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines

Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma

Ipca Laboratories receives three observations from USFDA for API facility at Tarapur

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

Solara’s Mangalore facility clears FDA inspection with VAI status