Drugs

FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis EMERYVILLE, Calif.–(BUSINESS WIRE) June 24, 2021 –Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on eye care, today announced that the U.S. Food and Drug Administration (FDA) has approved Verkazia (cyclosporine ophthalmic emulsion) 0.1%

June 21, 2021 — Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at

Treatment for Molluscum Contagiosum Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum WEST CHESTER, PA – May 28, 2021 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the

First precision therapy that specifically targets the primary driver of the disease Durable clinical responses, including complete remissions, shown in patients with or without prior treatment Full approval supported by robust efficacy and safety data from two clinical trials — CAMBRIDGE, Mass., June 16, 2021 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that

palovarotene Treatment for Fibrodysplasia Ossificans Progressiva Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP) PARIS, FRANCE, 28 May 2021 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the

FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use WHIPPANY, N.J.–(BUSINESS WIRE) June 17, 2021– Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Astepro Allergy (Azelastine HCI .15%) as an over-the-counter (OTC) product for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay

plinabulin Treatment for Neutropenia Associated with Chemotherapy BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN) NEW YORK, June 01, 2021 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer

June 16, 2021 Audience: Consumer What safety concern is FDA announcing? The U.S. Food and Drug Administration (FDA) is warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin. These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure

Treatment for Opioid Overdose Adamis Provides Update on Zimhi SAN DIEGO, June 09, 2021 (GLOBE NEWSWIRE) – Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for ZIMHI™, which is its higher naloxone injection product candidate for the treatment of opioid overdose. Adamis received

FDA Approves Rezipres (ephedrine hydrochloride injection) for Hypotension During Anesthesia DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres (ephedrine hydrochloride injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia. “We are

ruxolitinib Treatment for Atopic Dermatitis, Vitiligo Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis WILMINGTON, Del.–(BUSINESS WIRE) June 11, 2021 — Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New

BOSTON–(BUSINESS WIRE)–Jun. 7, 2021– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Ultomiris (ravulizumab-cwvz) to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris, a long-acting C5 inhibitor that offers immediate, complete and sustained complement inhibition, is now the first and only

FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 10, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV

June 11, 2021 Audience:  Patient, Health Professional, Pharmacy  Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits.

BOSTON, June 01, 2021 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s

EAST HANOVER, N.J., June 1, 2021 /PRNewswire/ — Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy1. This is the

FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Helps protect against more serotypes

BOSTON–(BUSINESS WIRE)–Jun. 9, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a

FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1 LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”) announced today that the U.S. Food & Drug Administration (FDA) has approved Ryplazim (plasminogen, human-tvmh) (“Ryplazim”) for the treatment of patients

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Tembexa (brincidofovir) tablets and oral suspension approval

Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark Research Triangle Park, NC, May 28, 2021 – Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug

oteseconazole Treatment for Vaginal Candidiasis Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis DURHAM, N.C.–(BUSINESS WIRE) June 01, 2021 — Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is used with a reduced calorie meal plan and

vadadustat Treatment for Anemia Associated with Chronic Renal Failure Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ – Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with

PRINCETON, N.J.–(BUSINESS WIRE) May 27, 2021 — Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).1 Zeposia, an oral medication taken once daily, is the first

pacritinib Treatment for Myelofibrosis CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis SEATTLE, June 1, 2021 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia

FDA Approves Brexafemme (ibrexafungerp) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) — Scynexis, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has