Drugs

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.

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

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

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

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

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

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

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

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

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

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

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

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:

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

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 –

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

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

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

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

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

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

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)

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

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain Print this page ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults

September 8, 2020 Print this page Audience: Health Professional, Pharmacy September 8, 2020 — FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug

Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its NDA for Pedmark To Prevent Ototoxicity Associated With Cisplatin Print this page RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter

September 3, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 3, 2020 — RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from

News FDA Alerts Corgiomed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL September 3, 2020 Print this page Audience: Consumer, Health Professional September 3, 2020 — CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer