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8889 News Found

USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Drug Approval | December 21, 2024

USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC

Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the


Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP
Drug Approval | December 20, 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)


Zaynich enables US cancer patient undergo successful liver transplant and resume chemotherapy
News | December 17, 2024

Zaynich enables US cancer patient undergo successful liver transplant and resume chemotherapy

In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND


Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ
Drug Approval | December 17, 2024

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market


Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion
Drug Approval | December 17, 2024

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery


Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL
News | December 17, 2024

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL

According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million


Pharmaceuticals & Medical Devices Bureau of India partnered with cooperative sector to open Jan Aushadhi Kendras through PACS
Policy | December 16, 2024

Pharmaceuticals & Medical Devices Bureau of India partnered with cooperative sector to open Jan Aushadhi Kendras through PACS

Till 30th November 2024, more than 2690 PACS have been given initial approval and 687 Kendras have been opened in PACS


Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension
Drug Approval | December 09, 2024

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen


Suven to acquire 56% stake in ADC specialist NJ Bio for US$64.4 million
News | December 09, 2024

Suven to acquire 56% stake in ADC specialist NJ Bio for US$64.4 million

This acquisition positions Suven as a key player in one of the fastest growing segments of the Pharma CDMO landscape


Laurus Labs invests in Laurus Bio
News | December 09, 2024

Laurus Labs invests in Laurus Bio