Drugs

Treatment for Presbyopia Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia NORTH CHICAGO, Ill., Feb. 25, 2021 /PRNewswire/ – Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of

NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, Humira induced clinical remission at Week 8 and maintained

Treatment for Narcolepsy Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy DUBLIN, Ireland, March 01, 2021 (GLOBE NEWSWIRE) – Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for FT218,

bardoxolone Treatment for Alport Syndrome Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome PLANO, Texas, March 01, 2021 (GLOBE NEWSWIRE) — Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that it has submitted a New Drug Application (“NDA”) for bardoxolone methyl (“bardoxolone”) for the treatment of

FDA Approves Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules for the Once-Daily Treatment for ADHD CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for

gefapixant Treatment for Cough U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review KENILWORTH, N.J.–(BUSINESS WIRE) March 1, 2021 — 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 for review the company’s New Drug Application (NDA) for gefapixant,

FDA Approves Pepaxto (melphalan flufenamide) for Patients with Relapsed or Refractory Multiple Myeloma STOCKHOLM, Feb. 26, 2021 /PRNewswire/ — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration, FDA, has approved Pepaxto (melphalan flufenamide, also

FDA Approves Nulibry (fosdenopterin) to Reduce the Risk of Mortality in Patients with Molybdenum Cofactor Deficiency (MoCD) Type A PALO ALTO, February 28, 2021 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and affiliate Origin Biosciences, Inc. (Origin) today announced the U.S. Food and Drug Administration (FDA) has approved Nulibry (fosdenopterin) for Injection as the first

FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45 CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) —  Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Amondys

maralixibat Treatment for Cholestatic Pruritus in Patients with Alagille Syndrome Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome FOSTER CITY, Calif.–(BUSINESS WIRE)–Feb. 1, 2021– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for maralixibat for the

Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients ROCKVILLE, Md., Feb. 08, 2021 (GLOBE NEWSWIRE) – Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its

tisotumab vedotin Treatment for Cervical Cancer Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer COPENHAGEN, Denmark and BOTHELL, Wash.; Feb 10, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug

TARRYTOWN, N.Y. and PARIS, Feb. 22, 2021 /PRNewswire/ – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an

ruxolitinib Treatment for Atopic Dermatitis, Vitiligo Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis WILMINGTON, Del.–(BUSINESS WIRE) February 19, 2021 — Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2

RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2021 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Rapivab® (peramivir injection) expanding the patient population of Rapivab for the treatment of acute uncomplicated influenza to include patients six months and

EAST HANOVER, N.J., Feb. 16, 2021 – Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.1 Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.1 The

NORTH CHICAGO, Ill., Feb. 10, 2021 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved Botox® for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients 5 years of age and older who have an inadequate response to

FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Cosela (trilaciclib) for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult

FDA Approves Evkeeza (evinacumab-dgnb) for Patients with Homozygous Familial Hypercholesterolemia TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) approved Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years

TARRYTOWN, N.Y. and PARIS, Feb. 9, 2021 /PRNewswire/ – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for

FDA Approves Breyanzi (lisocabtagene maraleucel) CAR-T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma PRINCETON, N.J.–(BUSINESS WIRE) February 5, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for

FDA Approves Ukoniq (umbralisib) for Marginal Zone Lymphoma and Follicular Lymphoma NEW YORK, Feb. 05, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has approved Ukoniq™ (umbralisib), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at

February 3, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy February 03, 2021 — Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to

EMERYVILLE, Calif.–(BUSINESS WIRE)–Feb. 1, 2021– Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for Gocovri® (amantadine) extended release

February 4, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy February 4, 2021 — The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to

FDA Approves Tepmetko (tepotinib) as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations ROCKLAND, Mass., Feb. 3, 2021 /PRNewswire/ — EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA)

FDA Approves Posimir (bupivacaine) for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression CUPERTINO, Calif., Feb. 2, 2021 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under

aducanumab Treatment for Alzheimer’s Disease Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review