Drugs

FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Print this page PLANEGG/MUNICH, Germany – August 1, 2020 and WILMINGTON, Del. – July 31, 2020 MorphoSys AG NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi

arimoclomol Treatment for Niemann-Pick Disease, type C Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C Print this page Copenhagen, Denmark, July 20, 2020 – Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response in order to develop and commercialize novel therapeutics for the

July 30, 2020 Print this page Audience: Consumer, Health Professional ISSUE: 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. The agency is aware of people

voclosporin Treatment for Lupus Nephritis Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis Print this page VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE) July 21, 2020 — Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”),

Treatment for Congestive Heart Failure scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission Print this page BURLINGTON, Mass.–(BUSINESS WIRE)–Jul. 27, 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

FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the Maintenance Treatment of COPD Print this page 24 July 2020 — AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the US Food and Drug Administration (FDA) was based on

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice Print this page HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE) July 27, 2020 –Dr. Reddy’s Laboratories Ltd. today announced approval of Xeglyze (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration. The approval triggers the contractual pre-commercialization milestone of $20 million

July 27, 2020 Print this page Audience: Consumers, Health Care Professionals July 27, 2020 — The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and

FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma Print this page SANTA MONICA, Calif.–(BUSINESS WIRE)–Jul. 24, 2020– Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only

July 22, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy July 22, 2020 — Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility

FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis Print this page COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / — MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has

FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy Print this page DUBLIN, July 22, 2020 /PRNewswire/ – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of

News FDA Alerts Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder – FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing July 23, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder

terlipressin Treatment for Hepatorenal Syndrome Type 1 Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1) Print this page DUBLIN, July 15, 2020 /PRNewswire/ – Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S.

Print this page AACHEN, Germany and MORRISTOWN, N.J., July 21, 2020 /PRNewswire/ — Grünenthal announced today that its U.S. subsidiary Averitas Pharma, Inc. received U.S. Food and Drug Administration (FDA) approval for Qutenza (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.[2] Qutenza is

vericiguat Treatment for Heart Failure with Reduced Ejection Fraction (HFrEF) FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat Print this page KENILWORTH, N.J.–(BUSINESS WIRE) July 16, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted

Treatment for Molluscum Contagiosum Verrica Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum Print this page WEST CHESTER, Pa., July 14, 2020 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced

Print this page HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.[1],[2] Tremfya is the first treatment

avacopan Treatment for ANCA-Associated Vasculitis ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis Print this page MOUNTAIN VIEW, Calif., July 09, 2020 (GLOBE NEWSWIRE) – ChemoCentryx, Inc., (NASDAQ: CCXI) today confirmed that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avacopan for the treatment

Print this page CAMBRIDGE, Mass.–(BUSINESS WIRE) July 09, 2020 –Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was

Print this page NORTH CHICAGO, Ill., July 9, 2020 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox® for the treatment of spasticity in pediatric patients 2 years of age and older, including

FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira Print this page HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ – Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years

FDA Approves Upneeq (oxymetazoline hydrochloride ophthalmic solution) for Acquired Blepharoptosis (Droopy Eyelid) in Adults Print this page BRIDGEWATER, N.J, July 09, 2020 (GLOBE NEWSWIRE) — Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Upneeq (oxymetazoline hydrochloride ophthalmic

Treatment for Molluscum Contagiosum Verrica Pharmaceuticals Provides Regulatory Update on VP-102 Print this page WEST CHESTER, Pa., June 29, 2020 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced that, on June 24, 2020, the Company received a letter from the U.S. Food and Drug Administration (FDA) as

aducanumab Treatment for Alzheimer’s Disease Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease Print this page CAMBRIDGE, Mass. and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics

FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML) Print this page Pleasanton, CA, Princeton, NJ, and Tokyo, Japan, July 7, 2020. Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved Inqovi

July 8, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy July 8, 2020 — Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain

July 7, 2020 Print this page Audience: Health Professional, Pharmacy July 7, 2020 — Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in