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.
Deal activity is rampant as Big Pharma gobbles up next-generation medicines and technologies to help overcome maturing pipelines and biosimilar threats.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
Sun Pharmaceutical Industries received approval from the U.S. Food and Drug Administration for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer.
Novartis’ Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
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.
The decision by U.S. regulators to finally approve AstraZeneca’s much-delayed excess potassium drug Lokelma gives the group another new medicine launch.
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.
The U.S. FDA approved a new treatment to help patients manage withdrawal symptoms from opioid addiction.
The U.S. FDA listed drugmakers who the regulator says are potentially blocking access to samples of their drugs to delay generic competition.
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.
Pfizer Inc.’s Retacrit was approved by U.S. health regulators as a biosimilar to current anemia treatments from Amgen Inc. and Johnson & Johnson.
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.
The U.S. FDA expanded the use of Novartis AG’s relapsing multiple sclerosis drug Gilenya to treat children and adolescents.
Specialty pharmaceutical company AcelRx Pharmaceuticals Inc. announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. FDA.
Kindred Biosciences Inc. received the first U.S. approval for a treatment for unintended weight loss in cats.
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.
The U.S. Food and Drug Administration approved Novartis AG’s Tafinlar and Mekinist combination therapy to treat an aggressive type of thyroid cancer.
Sarepta Therapeutics shares slipped after a European Medicines Agency committee rejected Exondys 51 (eteplirsen), the company’s treatment for Duchenne muscular dystrophy.
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.
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.
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.