Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs | News
Search Refinements

Regulatory Affairs News

View news from other Pharmaceutical sectors:
151-165 of 3467 results
UK NICE rejects Roche’s Perjeta breast cancer drug
By PBR Staff Writer
UK’s National Institute for Health and Care Excellence (NICE) has rejected Roche’s Perjeta treatment for breast cancer claiming that it is pricey and would not offer value for money.
Regulatory Affairs > News
FDA approves Genentech's Atezolizumab for advanced urothelial carcinoma
By PBR Staff Writer
Genentech has secured approval from the US Food and Drug Administration for its Tecentriq (atezolizumab) to treat the most common type of bladder cancer, dubbed urothelial carcinoma.
Regulatory Affairs > News
EC grants marketing authorization for Actelion's Uptravi to treat pulmonary arterial hypertension
The European Commission (EC) has granted marketing authorization in the EU for Actelion's orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag) to treat pulmonary arterial hypertension.
Regulatory Affairs > News
FDA approves Bristol-Myers Squibb's Opdivo for classical Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted accelerated approval for Bristol-Myers Squibb's Opdivo (nivolumab) to treat patients with classical Hodgkin lymphoma (cHL).
Regulatory Affairs > News
FDA approves Eisai's Lenvima to treat advanced renal cell carcinoma in combination with Everolimus
The U.S. Food and Drug Administration (FDA) approved LENVIMA (lenvatinib), Eisai's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy.
Regulatory Affairs > News
European Commission approves Alprolix treat haemophilia B
Swedish Orphan Biovitrum AB and Biogen announced that the European Commission (EC) has approved Alprolix (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation.
Regulatory Affairs > News
European Commission approves Bristol-Myers Squibb's two new oncology treatments
By PBR Staff Writer
The European Commission (EC) has approved two new oncology treatments, one for advanced melanoma and the other for multiple myeloma.
Regulatory Affairs > News
FDA expands Imbruvica label to include survival data
By PBR Staff Writer
The US Food and Drug Administration (FDA) has expanded Imbruvica (ibrutinib) label to include overall survival (OS) data in previously untreated chronic lymphocytic leukemia.
Regulatory Affairs > News
FDA approves new formulation of Eisai’s Fycompa to treat seizure disorders
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Eisai’s Fycompa (perampanel) oral suspension as adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures.
Regulatory Affairs > News
FDA approves Acadia's Nuplazid to treat Parkinson’s disease psychosis
By PBR Staff Writer
Acadia Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
Regulatory Affairs > News
Neovacs wins FDA approval to extend phase IIb clinical trial in Lupus to US
The US Food and Drug Administration (FDA) has approved Neovacs' investigational new drug application to extend its ongoing Phase IIb clinical trial of IFNα Kinoid to treat Lupus.
Regulatory Affairs > News
European Commission grants marketing authorisation to Lonsurf in mCRC
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for Taiho Pharmaceutical's Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, to treat advanced metastatic colorectal cancer (mCRC).
Regulatory Affairs > News
Collegium Pharmaceutical's Xtampza ER opioid painkiller wins FDA approval
By PBR Staff Writer
Collegium Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for Xtampza ER (oxycodone), a novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain.
Regulatory Affairs > News
FDA committee votes against approval of Sarepta's duchenne muscular dystrophy drug
The US Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review Sarepta Therapeutics' new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 skipping.
Regulatory Affairs > News
Gilead Sciences secures EU approval for new HIV treatment
By PBR Staff Writer
Gilead Sciences has secured marketing authorization from the European Commission (EC) for its fixed-dose combination Descovy (emtricitabine, tenofovir alafenamide) to treat HIV-1 infection.
Regulatory Affairs > News
151-165 of 3467 results