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136-150 of 1839 results
Synergy Pharmaceuticals provides update on FDA review of Plecanatide CIC NDA
Synergy Pharmaceuticals has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC).
Production & Manufacturing > Process & Production > News
FDA issues complete response letter for Elite's SequestOx new drug application
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (the “CRL”) regarding Elite Pharmaceuticals' New Drug Application (the “NDA”) for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride) investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
Production & Manufacturing > Process & Production > News
Amgen to discuss data supporting ABP 501 BLA with FDA
Amgen announced that it will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee.
Production & Manufacturing > Process & Production > News
US FDA grants orphan drug designation for Mazindol to treat narcolepsy
NLS Pharma Group (NLS) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Mazindol for the treatment of narcolepsy.
Production & Manufacturing > Process & Production > News
FDA grants AbbVie's ABT-414 rare pediatric disease designation to treat DIPG pediatric brain tumor
By PBR Staff Writer
AbbVie has secured rare pediatric disease designation from the US Food and Drug Administration (FDA) for investigational ABT-414 antibody drug conjugate (ADC) to treat Diffuse Intrinsic Pontine Glioma (DIPG) pediatric brain tumor.
Production & Manufacturing > Process & Production > News
FDA accepts Revive Therapeutics' IND of Bucillamine to treat cystinuria
The US Food and Drug Administration (FDA) has accepted Revive Therapeutics' Investigational New Drug Application ("IND") for a Phase 2 clinical study in the US of Bucillamine for the treatment of cystinuria.
Production & Manufacturing > Process & Production > News
FDA accepts Cempra's Solithera NDAs to treat community-acquired bacterial pneumonia
Cempra announced that its New Drug Applications (NDAs) for the approval of Solithera (solithromycin) as a treatment for community-acquired bacterial pneumonia (CABP) have been accepted for filing by the US Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
AB Science provides updates on marketing authorization application of masitinib
AB Science announced that the Committee for Medicinal Products for Human Use (CHMP) did not recommend at this time the accelerated assessment and therefore the review of the conditional marketing authorization application of masitinib in amyotrophic lateral sclerosis (ALS) will follow the standard timeline of the European Medicines Agency (EMA).
Production & Manufacturing > Process & Production > News
UK’s NICE recommends Ferring’s Firmagon for men with advanced hormone-dependent prostate cancer
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Ferring Pharmaceuticals’ Firmagon (degarelix) for men with advanced-hormone dependent prostate cancer and spinal metastases.
Production & Manufacturing > Process & Production > News
EC grants orphan drug status to Mereo's BPS-804 for osteogenesis imperfecta
By PBR Staff Writer
Mereo BioPharma Group announced that its drug BPS-804 has been granted orphan drug designation by the European Commission (EC) in the treatment of osteogenesis imperfecta (OI).
Production & Manufacturing > Process & Production > News
FDA grants Imbruvica breakthrough therapy designation for cGVHD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation (BTD) and an orphan drug designation for ibrutinib (Imbruvica) for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
Production & Manufacturing > Process & Production > News
EMA and FDA accept for review Roche’s Ocrevus for two forms of multiple sclerosis
By PBR Staff Writer
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted to review Roche’s marketing applications for Ocrevus (ocrelizumab) to treat two forms of multiple sclerosis.
Production & Manufacturing > Process & Production > News
Bristol-Myers Squibb’s Opdivo gets FDA breakthrough therapy designation for advanced form of bladder cancer
Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
Production & Manufacturing > Process & Production > News
EMA committee recommends approval of Merck’s Keytruda for advanced NSCLC
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Merck’s Keytruda (pembrolizumab) to treat advanced or metastatic non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
EMA committee recommends approval of Teva’s Cinqaero asthma drug
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Teva Pharmaceutical Industries' Cinqaero (reslizumab) asthma drug.
Production & Manufacturing > Process & Production > News
136-150 of 1839 results