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FDA Approves Symproic for OIC

The U.S. FDA approved Symproic (naldemedine) 0.2 mg tablets C-II for treating opioid-induced constipation in adult patients with chronic non-cancer pain.

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FDA Grants Approval for Bavencio

The U.S. FDA approved Bavencio (avelumab) Injection 20 mg/mL for ttreating adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.

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Romania bids to host EU drug agency after Brexit

Romania wants Brussels to relocate its pan-European drug regulator EMA to Bucharest from London after Brexit, the government said.

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European Approval for Label Extension of Cinryze

The European Commission approved a label extension for three new indications for Shire’s Cinryze, broadening its use to children with hereditary angioedema.

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FDA product review fees may double or more

The cost to healthcare companies for U.S. regulatory review of their products would more than double under the Trump administration’s proposed 2018 budget.

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China Food and Drug Administration Approves Xeljanz

Pfizer China announced that it has received approval from the CFDA to market its oral Janus kinase inhibitor, Xeljanz (tofacitinib citrate), in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

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GSK files for new Fluarix Quadrivalent indication

GlaxoSmithKline announces U.S. regulatory submission seeking expanded indication for Fluarix Quadrivalent (Influenza Vaccine) for infants 6 months and older.

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Merck’s Keytruda wins FDA nod for treating blood cancer

Merck & Co. Inc. said it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer.

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Novartis wins U.S. approval for breast cancer drug; to compete with Pfizer’s Ibrance

Novartis won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women who have a difficult-to-treat form of breast cancer, challenging U.S. rival Pfizer’s Ibrance.

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It’s Official: Trump Nominates Scott Gottlieb for Top FDA Job

President Donald Trump tapped the former deputy commissioner of the U.S. Food and Drug Administration, Dr. Scott Gottlieb, to helm the regulatory agency.

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FDA Approves First Treatment for Nocturia

Serenity Pharmaceuticals announced that the U.S. FDA approved Noctiva (desmopressin acetate), the first FDA-approved therapy for nocturia.

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FDA approves carcinoid syndrome diarrhea drug

The U.S. FDA approved Lexicon Pharmaceuticals Inc.’s oral drug to treat carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors.

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FDA warns Pfizer over contaminated drugs at Kansas plant

The U.S. FDA said Pfizer’s process for manufacturing sterile injectable drugs at a plant in McPherson, Kansas was “out of control” and put patients at risk, according to a warning letter.

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Novartis wins CHMP nod for cancer drug combo

Novartis’ drugs Tafinlar and Mekinist edged closer to approval in Europe to be used together against a type of lung cancer.

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Novartis cancer drug Zykadia gets FDA priority review

The U.S. Food and Drug Administration (FDA) has granted priority review to the Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said.

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First-Ever Device for Fast and Virtually Painless Blood Draw Receives FDA Clearance

Seventh Sense Biosystems Inc. (7SBio) announced that a new blood collection device called TAP has received U.S. Food and Drug Administration 510(k) clearance. The technology represents a landmark innovation in the blood collection industry where one billion blood draws are performed each year for diagnostic testing.

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FDA Accepts NDA Resubmission for DEXTENZA

Ocular Therapeutix’s NDA resubmission for DEXTENZA 0.4 mg for ocular pain occurring after ophthalmic surgery was accepted as a filing for review by FDA.

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FDA rejects Amphastar’s nasal opioid overdose treatment

Amphastar Pharmaceuticals Inc. said the U.S. Food and Drug Administration had rejected its application to market an intranasal version of the emergency opioid-overdose treatment, naloxone.

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U.S. FDA Accepts BLA for Mylan and Biocon’s Proposed Biosimilar Pegfilgrastim for Review

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

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FDA approves Valeant’s drug to treat plaque psoriasis

The U.S. Food and Drug Administration approved Valeant Pharmaceuticals International’s Siliq to treat adults with moderate-to-severe plaque psoriasis.

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