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Results For "FDA"

2061 News Found

Moderna posts Q1 2024 revenues at US$167 million
News | May 03, 2024

Moderna posts Q1 2024 revenues at US$167 million

GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)


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


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


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue


Vertex announces advancements of Suzetrigine in acute and neuropathic pain
News | April 22, 2024

Vertex announces advancements of Suzetrigine in acute and neuropathic pain

Breakthrough Therapy designation for pain associated with DPN granted by FDA