Drugs

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency Print this page DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved
0 Comments
Treatment for Molybdenum Cofactor Deficiency (MoCD) Type A BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A Print this page SAN FRANCISCO, September 29, 2020 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Origin Biosciences today announced the US Food and
0 Comments
Print this page NEW YORK–(BUSINESS WIRE) September 28, 2020 — Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and
0 Comments
Treatment for Seizure Clusters Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters Print this page WARREN, N.J., Sept. 25, 2020 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve
0 Comments
Print this page LAVAL, QC and DEER PARK, Ill., Sept. 25, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc. (NASDAQ: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Alaway® Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye
0 Comments
idecabtagene vicleucel Treatment for Multiple Myeloma U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) Print this page PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE) September 22, 2020 — Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc.
0 Comments
Print this page London UK 25 September 2020 — GlaxoSmithKline plc (GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause. The approval makes
0 Comments
September 23, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 23, 2020 — Sun Pharmaceutical Industries, Inc. (Sun Pharma), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of Riomet ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason
0 Comments
pegcetacoplan Treatment for Paroxysmal Nocturnal Hemoglobinuria Apellis Announces Submission of Pegcetacoplan Marketing Applications to FDA and EMA for Patients with PNH Print this page WALTHAM, Mass., Sept. 15, 2020 (GLOBE NEWSWIRE) – Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company has submitted a New Drug Application (NDA) to the
0 Comments
September 24, 2020 Print this page Audience: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of news reports of teenagers ending up in emergency rooms
0 Comments
loncastuximab tesirine Treatment for Diffuse Large B-cell Lymphoma ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma Print this page LAUSANNE, Switzerland–(BUSINESS WIRE)– September 24, 2020 — ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company
0 Comments
News FDA Alerts Drug Safety Communication: Benzodiazepine Drug Class – Boxed Warning Updated to Improve Safe Use September 23, 2020 Print this page Audience: Patient, Health Professional, Pharmacy ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This
0 Comments
umbralisib Treatment for Marginal Zone Lymphoma; Follicular lymphoma TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma Print this page NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) – TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted
0 Comments
vosoritide Treatment for Achondroplasia BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia Print this page SAN RAFAEL, Calif., Aug. 20, 2020 /PRNewswire/ – BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for
0 Comments
News FDA Alerts FDA Alerts of Perrigo’s Voluntary Albuterol Inhaler Recall September 21, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 21, 2020 — The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions
0 Comments
September 17, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 17, 2020 — Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots
0 Comments
veverimer Treatment for Metabolic Acidosis in Chronic Kidney Disease Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD Print this page SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Aug. 24, 2020– Tricida, Inc. (Nasdaq:
0 Comments
casimersen Treatment for Duchenne Muscular Dystrophy Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45 Print this page CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the
0 Comments
tepotinib Treatment for Non-Small Cell Lung Cancer FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations Print this page ROCKLAND, Mass., Aug. 25, 2020 /PRNewswire/ – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug
0 Comments
News New Drug Applications Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C arimoclomol Treatment for Niemann-Pick Disease, type C Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C Print this page Copenhagen, Denmark, September 16, 2020 –
0 Comments
terlipressin Treatment for Hepatorenal Syndrome Type 1 Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1) Print this page DUBLIN, Sept. 14, 2020 /PRNewswire/ – Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued
0 Comments
FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent Print this page Houston, TX and St. Louis, MO, Sept. 08, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA).  Detectnet
0 Comments
Print this page NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that its New Drug Application (NDA) for Epsolay® (benzoyl peroxide), an investigational proprietary topical cream for the treatment of
0 Comments
trilaciclib Treatment for Small Cell Lung Cancer G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer Print this page RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) – G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New
0 Comments
Print this page London UK 9 September 2020 — GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to
0 Comments
Print this page INDIANAPOLIS, Sept. 3, 2020 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company’s (NYSE: LLY) Trulicity® (dulaglutide). The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase 3 trial showed the additional doses led to
0 Comments
maralixibat Treatment for Cholestatic Pruritus in Patients with Alagille Syndrome Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program Print this page FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 1, 2020– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on
0 Comments
FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer Print this page South San Francisco, CA — September 4, 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 Gavreto (pralsetinib)
0 Comments