Drugs

Treatment for Congestive Heart Failure scPharmaceuticals Announces Furoscix NDA Resubmission Print this page BURLINGTON, Mass.–(BUSINESS WIRE)–Jul. 1, 2020– scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has resubmitted
0 Comments
Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 29, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch
0 Comments
FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available Print this page July 2, 2020 — ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg
0 Comments
udenafil Treatment for Single Ventricle Heart Disease Mezzion Announces Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease Print this page SEOUL, South Korea, June 30, 2020 /PRNewswire/ – Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has submitted a New Drug
0 Comments
FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation Print this page Dublin, Ireland – 2 July 2020: Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved Byfavo (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or
0 Comments
pralsetinib Treatment for Thyroid Cancer Blueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers Print this page CAMBRIDGE, Mass., July 1, 2020 /PRNewswire/ – Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today
0 Comments
Print this page Rockland, MA and New York, US, JUNE 30, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Bavencio (avelumab) for
0 Comments
Treatment for Postoperative Pain Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain Print this page SAN DIEGO, June 29, 2020 /PRNewswire/ – Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today
0 Comments
FDA Approves Dojolvi (triheptanoin) for the Treatment of Long-Chain Fatty Acid Oxidation Disorders Print this page NOVATO, Calif., June 30, 2020 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved
0 Comments
FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer Print this page South San Francisco, CA — June 29, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo, a fixed-dose combination (FDC) of Perjeta® (pertuzumab)
0 Comments
casimersen Treatment for Duchenne Muscular Dystrophy Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45 Print this page CAMBRIDGE, Mass., June 26, 2020 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today
0 Comments
Print this page CAMBRIDGE, Mass. and TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). The pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with
0 Comments
FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome Print this page EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Fintepla (fenfluramine) oral solution, CIV for the
0 Comments
FDA Approves Mycapssa (octreotide) Oral Somatostatin Analog for Acromegaly Print this page NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and
0 Comments
Print this page NEWTON, Mass., June 22, 2020 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio® (selinexor), the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse
0 Comments
Treatment for Contraception Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US Print this page ADELAIDE, Australia, June 24, 2020 /PRNewswire/ — Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food
0 Comments
Print this page KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by
0 Comments
Treatment for Urinary Tract Infection Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Contepo (fosfomycin) for injection Print this page DUBLIN, Ireland, June 19, 2020 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today
0 Comments
Print this page CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jun. 18, 2020– Epizyme, Inc. (Nasdaq:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) for the following two distinct follicular lymphoma (FL) indications: Adult patients with relapsed
0 Comments
Print this page NOVATO, Calif. and TOKYO, June 18, 2020 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions using the
0 Comments
June 18, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 18, 2020 — GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups.
0 Comments