Drugs

FDA Approves Qwo (collagenase clostridium histolyticum-aaes) as the First Injectable Treatment for Cellulite Print this page DUBLIN, July 6, 2020 /PRNewswire/ — Endo International plc (NASDAQ: ENDP) today announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks

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

July 2, 2020 Print this page Audience: Consumers July 2, 2020 — FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol,

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

Print this page London, UK – 12 June 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 Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral

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

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

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.

Print this page EAST HANOVER, N.J., June 16, 2020 /PRNewswire/ — Novartis, a leader in rheumatology and immuno-dermatology, today announced that the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum9. “The results from

June 19, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 19, 2020 — FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. FDA

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis Print this page SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 17, 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 treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high

FDA Approves Lyumjev (insulin lispro-aabc injection) for Type 1 and Type 2 Diabetes Print this page INDIANAPOLIS, June 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s (NYSE: LLY) new rapid-acting insulin indicated to improve glycemic control in