FDA
Acacia Pharma secures first FDA approval with Barhemsys for postoperative nausea and vomiting
February 28, 2020Medical Communications, Sales and Marketing Acacia, FDA, UK, US, pharma
UK-based Acacia Pharma has secured its first US approval with the FDA’s decision to authorise Barhemsys (amisulpride injection) for the …
FDA advisory committee narrowly backs Eli Lilly’s Cyramza combo for metastatic EGFR+ NSCLC
February 27, 2020Sales and Marketing Eli Lilly, FDA, cyramza, pharms
Eli Lilly’s Cyramza (ramucirumab) has edged closer to US approval after it scored a recommendation from the FDA’s Oncologic Drugs …
Female participation up in 2019 US clinical trials, but minority representation down
February 27, 2020Medical Communications, Research and Development FDA, clinical trials, pharma
The FDA’s Drugs Trials Snapshots 2019 report has been released, clarifying the demographic distribution of participants who were included in …
US Judge rules that a decade of unpublished trial results must be made public
February 27, 2020Medical Communications, Research and Development FDA, US, clinical trials, pharma
A federal judge in New York’s Southern District has ruled that 10 years of unpublished clinical trial data must now …
First US coronavirus trial launched into Gilead’s remdesivir
February 26, 2020Research and Development FDA, Gilead, US, coronavirus, pharma
The first US clinical trial investigating a treatment for the COVID-19 coronavirus has been launched by the US National Institute …
FDA greenlights first oral, daily, non-statin therapy for lowering LDL-Cholesterol
February 25, 2020Manufacturing and Production, Sales and Marketing Esperion, FDA, Nexletol, pharma
Esperion’s ATP Citrase Lyase (ACL) inhibitor Nexletol (bempedoic acid) has secured approval from the FDA, it has emerged. It is …
FDA approves first adjuvanted quadrivalent flu vaccine in over-65s
February 24, 2020Sales and Marketing FDA, flu, influenza, pharma, seqirus
The FDA has just authorised its first adjuvanted quadrivalent influenza vaccine, it has been announced. Seqirus’ Fluad Quadrivalent (influenza vaccine, adjuvanted) …
Lundbeck’s Vyepti secures US approval for migraine prevention
February 24, 2020Sales and Marketing FDA, Lundbeck, Vyepti, migraine, pharma
Lundbeck’s Vyepti (eptinezumab-jjmr) has secured approval from the FDA, it has emerged, for the prevention of migraine in adult patients. …
FDA approval for Baudax Bio’s non-opioid painkiller Anjeso
February 24, 2020Sales and Marketing Anjeso, FDA, opioids, pharma
Baudax Bio has revealed the FDA approval of its non-opioid painkiller Anjeso (meloxicam injection) as a therapy for the management …
New Keytruda dosing schedule rejected in six cancers by the FDA
February 20, 2020Sales and Marketing Cancer, FDA, MSD, keytruda, pharma
MSD’s blockbuster immunotherapy Keytruda has been stopped in its tracks by the FDA after the US regulator rejected its application …
FDA approved over 1,000 generic drugs in 2019
February 20, 2020Research and Development, Sales and Marketing FDA, generic drugs, pharma
The FDA covered a lot of ground in 2019 when it came to generic drugs, awarding at least tentative approval …
CEO of PixarBio Corporation sentenced to prison for defrauding investors
February 19, 2020Research and Development Biopharmaceuticals, CEO, FDA, corruption, fraud, investors
Frank Reynolds, the CEO of Boston based PixarBio Corporation, was sentenced to seven years in prison for defrauding investors and …
FDA teams up with Indian government to crack down on illicit drugs shipments
February 19, 2020Research and Development FDA, FDA India, FDA trade, Indian Pharma
The FDA announced yesterday its first successful bilateral enforcement operation with the Government of India, where they stopped 500 shipments …
Lawsuit against FDA claims Bernie Sanders played role in approval of rival drug
February 17, 2020Research and Development, Sales and Marketing Bernie, Bernie Sanders, Catalyst Pharmaceuticals, FDA, TRUMP FDA, US FDA
Catalyst Pharmaceutical is attempting to show in court that pressure from US Senator Bernie Sanders led to the approval of …
Eisai withdraws weight loss drug Belviq after FDA highlights cancer risk
February 14, 2020Medical Communications, Research and Development, Sales and Marketing Belviq, Eisai, FDA, pharma
The FDA has requested that Eisai withdraw its weight loss drug Belviq (lorcaserin) and Belviq XR from the US market …
