Ironwood Pharmaceuticals and Allergan have reached an agreement with Mylan Pharmaceuticals to resolve patent litigations over Mylan’s abbreviated new drug applications (ANDAs) seeking approval to market generic versions of LINZESS (linaclotide) before the expiration of their applicable patents.
The US Food and Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients, aged one year or more.
Zydus Cadila, an Indian pharmaceutical company, has obtained final approval from the US Food and Drug Administration (FDA) to market Clindamycin Phosphate and Benzoyl Peroxide Gel.
The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.
The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate.
The US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab) injection for use in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
AstraZeneca’s partner FibroGen China has secured marketing approval from the China’s National Medical Products Administration (NMPA) for roxadustat to treat anemia in chronic kidney disease (CKD) patients on dialysis.
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).
Teva Pharmaceutical Industries, along with Celltrion, has secured approval from the US Food and Drug Administration (FDA) for breast cancer drug Herzuma (trastuzumab-pkrb), a biosimilar to Roche’s Herceptin.
Novartis has secured approval from the European Commission (EC) for Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.
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