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Maroc Maroc - DRUGS.COM - New Drug Approvals - 07/Aug 21:08

FDA Approves Zurnai (nalmefene hydrochloride) Auto-Injector for the Emergency Treatment of Known or Suspected Opioid Overdose

STAMFORD, Conn., August 7, 2024 – Purdue Pharma L.P. (“Purdue”) announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s new drug application for the Zurnai (nalmefene injection) Auto-Injector...

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Indies Pharma looking to double sales after securing FDA drug approval

jamaica-gleaner.com - 05:05

Drug company Indies Pharma Jamaica Limited is looking to double next year’s revenues, following approval of its abbreviated new drug application,...

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KalVista announces FDA acceptance of NDA for sebetralstat for oral on-demand treatment of HAE

haei.org - 03/Sep 17:29

KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...

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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

drugs.com - 03/Sep 20:09

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....

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Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

drugs.com - 29/Aug 04:08

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...

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Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

drugs.com - 29/Aug 04:08

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...

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North Carolina's residential opioid treatment services lack evidence-based approaches

news.medical.net - 29/Aug 05:13

A new study of organizations that claim to provide residential opioid substance use services in North Carolina found that only 12% of the...

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‘Significant milestone’ – EBR submits final PMA module to FDA

stockhead.com.au - 29/Aug 21:21

EBR Systems has submitted the final premarket approval (PMA) application module to the US Food and Drug Administration (FDA) for ...

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FDA Accepts AXSM's NDA Resubmission for Migraine Drug, Stock Up

zacks.com - 05/Sep 15:35

The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

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Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

drugs.com - 03/Sep 01:09

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing...

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Why are overdose deaths declining in Alberta?

ottawa.citynews.ca - 10/Sep 12:52

New data shows that opioid overdose deaths in Alberta from January-May fell from 788 in 2023 to 431 this year, a 55 percent decline. There are a...

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