Regulatory Review | India Pharma Industry

Lupin Gains US FDA Nod to Launch Generic HIV Drug in the US Market

Pharmaceutical company Lupin announced that it has received authorization from the US health authority to commercialize generic HIV drug in the US market. The Mumbai-based drug manufacturer announced in a statement that it has obtained provisional...

Roche Secures FDA Nod and CLIA Waiver for cobas liat STI

Roche reported that the US Food and Drug Administration (FDA) has provided 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat panels for multiplex testing of sexually transmitted infections...

Poxel SA Receives CNIPA Patent for Imeglimin

Poxel SA, a biopharmaceutical firm at the clinical stage focusing on developing groundbreaking therapies for chronic serious diseases characterized by metabolic pathophysiology, such as metabolic dysfunction-associated steatohepatitis (MASH)...

US FDA Lifts Hold on Sanofi's Trial to Make Cialis Available Over-the-Counter

Opella, the Consumer Healthcare division of Sanofi, announced that the US Food and Drug Administration (FDA) has removed a clinical hold on its proposed actual use trial (AUT) aimed at facilitating the transition of Cialis (tadalafil) from...

CCI Approves Merger of Nine Entities with Sequent Scientific

The Competition Commission approved the merger of nine entities with the pharmaceutical company Sequent Scientific Ltd (SSL). "The suggested merger entails a sequence of linked actions executed for the integration of SRL, Viyash, Symed, Appcure...

Integrating CSR into HR Practices to Enhance Brand Reputation in Pharma

Binita Shah, Co-founder of BDR Pharmaceuticals, engaged in a conversation with India Pharma Outlook, to explain how CSR is becoming integral to HR in the Indian pharma industry, focusing on community-driven initiatives like healthcare awareness,

GSK's Jemperli Gains EU Nod for First-Line Treatment of Endometrial Cancer

GSK plc announced that the European Commission has authorized Jemperli (dostarlimab) in conjunction with chemotherapy (carboplatin and paclitaxel) as a first-line therapy for adult patients with primary advanced or recurrent endometrial cancer...

Strides Pharma Bags USFDA Nod for OTC Acetaminophen-Ibuprofen Combo Tablets

Strides Pharma Science Limited has announced that its wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has obtained approval from the United States Food & Drug Administration (USFDA) for Acetaminophen and Ibuprofen Tablets...

US FDA Approves Amgen's Lumakras-Vectibix Combo for KRAS G12C-Mutated mCRC

Amgen announced that the US Food and Drug Administration (FDA) has granted approval for Lumakras (sotorasib) in conjunction with Vectibix (panitumumab) for treating adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC)...

AstraZeneca's Calquence Combo Secures US Nod for Mantle Cell Lymphoma

AstraZeneca's Calquence (acalabrutinib), combined with bendamustine and rituximab, has received approval in the US for treating adult patients with previously untreated mantle cell lymphoma (MCL) who cannot undergo autologous hematopoietic stem...