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

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

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

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

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

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

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

Briefs: Venus Remedies and GPT Healthcare

Venus Remedies secures marketing authorization in Philippines

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients