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FDA approves BioMarin rare metabolic disorder drug, shares rise

U.S. regulators approved BioMarin Pharmaceutical Inc.’s Palynziq for adults with phenylketonuria, a rare metabolic disorder, sending shares of the biotechnology company up 3 percent after hours.

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FDA Clears Sun Pharma’s Yonsa for Prostate Cancer

Sun Pharmaceutical Industries received approval from the U.S. Food and Drug Administration for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer.

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Novartis receives EU approval for biosimilar Zessly

Novartis’ Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.

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Warning letters issued to kratom-product sellers

The U.S. FDA issued warning letters to three companies that illegally marketed and distributed products containing the substance kratom, which they claimed treat opioid addiction and withdrawal.

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AstraZeneca potassium drug finally approved

The decision by U.S. regulators to finally approve AstraZeneca’s much-delayed excess potassium drug Lokelma gives the group another new medicine launch.

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U.S. FDA approves Amgen drug for prevention of migraines

Amgen Inc. won U.S. Food and Drug Administration approval for the first drug in a new class designed to prevent migraine headaches in adults.

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FDA Approves First Non-Opioid Treatment to Manage Opioid Addiction Withdrawal Symptoms

The U.S. FDA approved a new treatment to help patients manage withdrawal symptoms from opioid addiction.

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FDA names drugmakers potentially acting to delay cheap generics

The U.S. FDA listed drugmakers who the regulator says are potentially blocking access to samples of their drugs to delay generic competition.

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FDA declines to approve Botox rival

U.S. health regulators declined to approve Evolus Inc.’s rival product to Allergan Plc’s Botox, sending its shares down as much as 35 percent.

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Pfizer’s biosimilar of Amgen, J&J’s anemia treatments gets FDA nod

Pfizer Inc.’s Retacrit was approved by U.S. health regulators as a biosimilar to current anemia treatments from Amgen Inc. and Johnson & Johnson.

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FDA Rejects Perrigo’s Generic of Teva’s ProAir Inhaler

Perrigo expects the U.S. Food and Drug Administration to issue a Complete Response Letter for the company’s generic version of Teva Pharmaceutical’s ProAir asthma inhaler.

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FDA expands use of Novartis MS drug to pediatric patients

The U.S. FDA expanded the use of Novartis AG’s relapsing multiple sclerosis drug Gilenya to treat children and adolescents.

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AcelRx resubmits New Drug Application for DSUVIA

Specialty pharmaceutical company AcelRx Pharmaceuticals Inc. announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. FDA.

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FDA approves Kindred treatment for problem weight loss in cats

Kindred Biosciences Inc. received the first U.S. approval for a treatment for unintended weight loss in cats.

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FDA Gives Genentech’s Tecentriq Priority Review for Triple-Combo Lung Cancer Treatment

The FDA granted Genentech’s Tecentriq triple combination with Avastain, paclitaxel and carboplatin Priority Review for the first-line treatment of patients with metastatic NSCLC.

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FDA approves Novartis combo therapy for aggressive type of thyroid cancer

The U.S. Food and Drug Administration approved Novartis AG’s Tafinlar and Mekinist combination therapy to treat an aggressive type of thyroid cancer.

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CHMP Rejects Sarepta’s DMD Drug

Sarepta Therapeutics shares slipped after a European Medicines Agency committee rejected Exondys 51 (eteplirsen), the company’s treatment for Duchenne muscular dystrophy.

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FDA Issues CRL for Novartis Copycat

The U.S. FDA issued a complete response letter to Sandoz, a division of Novartis, for its Biologics Licensing Application for a biosimilar to Roche/Genentech’s Rituxan.

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U.S. approves Novartis cell therapy for lymphoma

The FDA approved Novartis’ cell therapy Kymriah for treating patients with a second type of blood cancer, large B-cell lymphoma, that has worsened despite two or more earlier lines of therapy.

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FDA clears Pluristem radiation treatment for emergency use

The U.S. Food and Drug Administration cleared the emergency use of Pluristem Therapeutics Inc.’s therapy PLX-R18 to treat acute radiation exposure in a nuclear event.

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