Drugs.com - New Drug Approvals New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
- FDA Approves Qsymia for Chronic Weight Management in Certain Pediatric Patients Aged 12 years and Olderon June 27, 2022 at 2:06 am
June 27, 2022 -- The U.S. Food and Drug Administration has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in pediatric patients aged 12 years and older who are...
- U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapyon June 24, 2022 at 1:06 am
In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with median event-free survival of 10.1 months vs. 2.3 months and a well-established safety profile Approval...
- Novartis Tafinlar + Mekinist Receives FDA Approval for First Tumor-Agnostic Indication for BRAF V600E Solid Tumorson June 23, 2022 at 2:06 am
Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation1,2...
- U.S. FDA Approves Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Childrenon June 22, 2022 at 10:06 pm
Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four-dose series and superior immune responses for important disease-causing shared serotype 3 and unique serotypes 22F...
- Skyrizi (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adultson June 17, 2022 at 12:06 am
Third approved indication for Skyrizi (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating Skyrizi in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and...
- Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Use in Patients with Bardet-Biedl Syndromeon June 16, 2022 at 10:06 pm
Imcivree now available for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome First and only FDA-approved therapy that targets impairment in the MC4R...
- FDA Approves Lilly and Incyte's Olumiant (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areataon June 13, 2022 at 2:06 am
INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib), a once-daily pill, as a first-in-disease...
- FDA Approves Amvuttra (vutrisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adultson June 13, 2022 at 2:06 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 13, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) approved Amvuttra (vutrisiran), an RNAi...
- FDA Approves Expansion of CellCept (mycophenolate mofetil) Indication to Pediatric Heart Transplant and Pediatric Liver Transplant Populationson June 8, 2022 at 10:06 pm
June 8, 2022 -- FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in pediatric recipients of allogenic heart and allogeneic liver transplants aged 3 months and older in combination with other...
- FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan (rituximab), for Adults with Moderate to Severe Rheumatoid Arthritison June 7, 2022 at 6:06 am
THOUSAND OAKS, Calif., June 6, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Riabni (rituximab-arrx), a biosimilar to Rituxan®, in combination with methotrexate for adults...
- FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitison June 7, 2022 at 3:06 am
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, and significantly reduced...
- FDA Approves Priorix (Measles, Mumps and Rubella Vaccine, Live) for the Prevention of Measles, Mumps and Rubella in Individuals 12 Months of Age and Olderon June 6, 2022 at 6:06 am
Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients London UK 06 June 2022 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and...
- Novartis Announces FDA Approval of Beovu for the Treatment of Diabetic Macular Edemaon June 1, 2022 at 2:06 am
Approval is based on year one data from the Phase III KESTREL and KITE clinical trials investigating Beovu (brolucizumab-dbll) 6 mg versus aflibercept 2 mg in DME patients1,2 In KESTREL and KITE, Beovu was non-inferior to aflibercept in change...
- FDA Approves Label Extension for Evrysdi for Infants with Spinal Muscular Atrophy Under 2 Months Oldon May 31, 2022 at 10:05 pm
SOUTH PLAINFIELD, N.J., May 31, 2022 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi (risdiplam) to include infants under 2 months old...
- U.S. Food and Drug Administration Approves Two Opdivo (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinomaon May 30, 2022 at 2:05 am
Opdivo in combination with chemotherapy and Opdivo plus Yervoy® (ipilimumab) approved based on a Phase 3 trial showing improved overall survival versus chemotherapy alone1,2 Opdivo-based treatments are now approved for five indications in...
- FDA Approves Novartis Kymriah CAR-T Cell Therapy for Adult Patients with Relapsed or Refractory Follicular Lymphomaon May 27, 2022 at 2:05 am
68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile1 Sustained clinical benefit from Kymriah treatment demonstrated – of patients...
- FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulastaon May 27, 2022 at 1:05 am
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- May 27, 2022 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the...
- United Therapeutics Announces FDA Approval of Tyvaso DPIon May 25, 2022 at 3:05 am
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE) May 24, 2022 -- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the U.S. Food and Drug Administration (FDA) has approved...
- Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemiaon May 25, 2022 at 3:05 am
Tibsovo is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia FDA approval based on data from the global, Phase 3 AGILE trial that...
- FDA Approves Vtama (tapinarof) Cream for the Treatment of Plaque Psoriasis in Adultson May 24, 2022 at 3:05 am
LONG BEACH, Calif., and BASEL, Switzerland, May 24, 2022 — Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the U.S. Food and Drug...