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1-15 of 3310 results
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
FDA removes clinical hold Cara Therapeutics' postoperative pain trial for I.V. CR845
By PBR Staff Writer
The US Food and Drug Administration (FDA) has removed the clinical hold on Cara Therapeutics' adaptive phase 3 clinical trial assessing an intravenous formulation (I.V.) of lead product candidate CR845 to treat postoperative pain.
Regulatory Affairs > News
FDA approves Boehringer Ingelheim's Gilotrif for squamous cell lung cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim's supplemental New Drug Application (sNDA) for Gilotrif (afatinib) as new oral treatment option for patients with squamous cell carcinoma (SqCC) of the lung.
Regulatory Affairs > News
FDA to review Bristol-Myers' Opdivo for classical Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb's supplemental Biologics License Application (sBLA) to expand the use of its cancer drug Opdivo to treat patients with classical Hodgkin lymphoma (cHL).
Regulatory Affairs > News
FDA committee votes against accelerated approval of Clovis' rociletinib lung cancer drug
By PBR Staff Writer
The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 12-1 against accelerated approval of Clovis Oncology's rociletinib lung cancer drug.
Regulatory Affairs > News
FDA grants orphan drug status to Appili's ATI-1501 to treat C. difficile in children
By PBR Staff Writer
Appili Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for ATI-1501, a taste-masked reformulation of metronidazole with the potential to treat Clostridium difficile infection (CDI) in children.
Regulatory Affairs > News
FDA approves Venclexta for tough-to-treat type of leukemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) to treat patients with chronic lymphocytic leukemia (CLL) with the 17p deletion who have received at least one prior therapy.
Regulatory Affairs > News
EC approves subcutaneous route of administration in Binocrit's nephrology indication
By PBR Staff Writer
Sandoz, the generic pharmaceuticals division of Novartis, has secured approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous (sc) route of administration in Binocrit’s nephrology indication.
Regulatory Affairs > News
FDA grants orphan drug designation to ANAVEX 3-71 to treat Frontotemporal dementia
By PBR Staff Writer
Clinical-stage biopharmaceutical firm Anavex Life Sciences has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for ANAVEX 3-71 to treat Frontotemporal dementia (FTD).
Regulatory Affairs > News
1-15 of 3310 results