pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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Competition FDA Pharmaceutical Marketing 114

pharmaphorum

AUGUST 3, 2022

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. The post Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod appeared first on.

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FDA Safety Sales Competition 59

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). 2007; 2(1):5-11. neffy, Epinephrine Nasal Spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at Risk of Anaphylaxis: Phase 3 Study Results. 2022 ; 17(11).

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

pharmaphorum

NOVEMBER 29, 2022

NT-I7 exhibits reliable Pharmacokinetic (PK) and safety profiles, making it an ideal combination partner. Across the current 14 on-going clinical trials, safety results have been very consistent: NT-I7 has demonstrated a well-tolerated safety profile. Several combinations being studied. He received his Ph.D.

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Safety Patients Engineering Recruitment 105

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. More recently, the FDA granted approval of Roctavian in June 2023.

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Consulting Manufacturing Side effects Safety 74

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.

Food and Drug Administration 40

Food and Drug Administration Food FDA Safety 40

European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Pharmacopoeia guidance on DEG and EG. 05 October 2022.

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Food and Drug Administration Manufacturing Safety Food 105