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1671 News Found

FDA grants full approval for TIVDAK to treat cervical cancer
Drug Approval | May 02, 2024

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer


Merck announces positive data for investigational, 21-Valent pneumococcal conjugate vaccine
Clinical Trials | May 02, 2024

Merck announces positive data for investigational, 21-Valent pneumococcal conjugate vaccine

Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases


Granules India announced ANDA Approval for Colchicine Capsules
Drug Approval | May 01, 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult


Gland Pharma appoints Satnam Singh Loomba as COO
People | April 29, 2024

Gland Pharma appoints Satnam Singh Loomba as COO

Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.


Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets
Drug Approval | April 29, 2024

Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets

Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA


Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
Drug Approval | April 28, 2024

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit


Zydus receives final approval from USFDA for Tretinoin Cream
Drug Approval | April 28, 2024

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)


CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU


FDA approves Biktarvy label update with data for pregnant adults with HIV
Drug Approval | April 27, 2024

FDA approves Biktarvy label update with data for pregnant adults with HIV

Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV