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Results For "US-Food-and-Drug-Administration"

135 News Found

GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion
News | June 03, 2022

GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion

GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


USFDA approves Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile


Propanc Biopharma undertaking PRP manufacturing & development for human use
Biotech | May 20, 2022

Propanc Biopharma undertaking PRP manufacturing & development for human use

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection


NORD announces over US $ 100,000 in grant funding available for rare disease research
Biotech | May 02, 2022

NORD announces over US $ 100,000 in grant funding available for rare disease research

Three RFPs now open for qualified researchers through NORD's Jayne Holtzer rare disease research grants program


Pharming gets positive review from UK MHRA for leniolisib
Biotech | April 26, 2022

Pharming gets positive review from UK MHRA for leniolisib

A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme


Zydus to supply Sagent's caffeine citrate oral solution from Jarod
Biotech | April 13, 2022

Zydus to supply Sagent's caffeine citrate oral solution from Jarod

This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants


Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors
Drug Approval | March 30, 2022

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding


Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes
Drug Approval | March 29, 2022

Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults


USFDA approves Novartis Pluvicto to treat prostrate cancer
Drug Approval | March 24, 2022

USFDA approves Novartis Pluvicto to treat prostrate cancer

USFDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions