FDA News, New Drug Approvals, Biotech and Pharmaceutical Stock News
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 PreHevbrio (Hepatitis B Vaccine (Recombinant)) for the Prevention of Hepatitis B in Adultson December 1, 2021 at 11:12 pm
PreHevbrio™ is the only approved 3-antigen hepatitis B vaccine for adults in the U.S. VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease,...
- FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgeryon November 29, 2021 at 8:11 pm
WEST LAFAYETTE, Ind., Nov. 29, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, today announced that the U.S. Food and...
- FDA Approves Livtencity (maribavir) for Post-Transplant Cytomegalovirus (CMV) Infection/Diseaseon November 23, 2021 at 10:11 pm
- In the Phase 3 SOLSTICE study, more than twice the proportion of adult transplant recipients with refractory or resistant (R/R) CMV infection/disease achieved confirmed CMV DNA level <LLOQ at Week 8 with Livtencity (56%; n=131/235), compared to...
- FDA Approves Fyarro (sirolimus protein-bound particles) for the Treatment of Malignant Perivascular Epithelioid Cell Tumor (PEComa)on November 23, 2021 at 7:11 pm
Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ultra-rare and aggressive form of sarcoma with a strong female predominance LOS ANGELES, Nov. 23, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc....
- FDA Approves Voxzogo (vosoritide) to Increase Linear Growth in Children with Achondroplasiaon November 19, 2021 at 9:11 pm
SAN RAFAEL, Calif., Nov. 19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Voxzogo™ (vosoritide) for Injection, indicated...
- FDA Approves Merck’s Keytruda (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgeryon November 18, 2021 at 9:11 pm
Keytruda Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions Keytruda Is the First Immunotherapy...
- FDA Approves Besremi (ropeginterferon alfa-2b-njft) for the Treatment of Adults With Polycythemia Veraon November 12, 2021 at 8:11 pm
BURLINGTON, Mass.--(BUSINESS WIRE) November 12, 2021 --PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology...
- FDA Approves Eprontia (topiramate) Oral Solution for Epilepsy and Preventive Treatment of Migraineon November 8, 2021 at 7:11 pm
WOBURN, MA, November 8, 2021 – Azurity Pharmaceuticals, Inc. a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved conditions, today announced the U.S. Food...
- Tris Pharma Announces FDA Approval of Dyanavel XR (amphetamine) Once-Daily Extended-Release Oral Tablets, CII, for ADHDon November 5, 2021 at 12:11 am
In a clinical study in adults, Dyanavel XR tablets demonstrated bioequivalence to Dyanavel XR (amphetamine) extended-release oral suspension. ADHD patients taking Dyanavel XR oral suspension can conveniently switch to the same dose of Dyanavel XR...
- FDA Approves Vuity (pilocarpine HCI ophthalmic solution) to Treat Presbyopia (Age-Related Blurry Near Vision)on October 29, 2021 at 11:10 pm
NORTH CHICAGO, Ill., Oct. 29, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced the U.S. Food and Drug Administration (FDA) approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia,...
- FDA Approves Scemblix (asciminib) for the Treatment of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)on October 29, 2021 at 9:10 pm
Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments1 In the pivotal...
- FDA Approves Xipere (triamcinolone acetonide injectable suspension) for the Treatment of Macular Edema Associated with Uveitison October 25, 2021 at 7:10 pm
XIPERE™ is the First and Only Medicine to be Approved in the United States for Delivery via Suprachoroidal Injection, a Method Designed to Facilitate Targeted Delivery of Therapeutic Agents to the Retina and Choroid LAVAL, QC and ALPHARETTA,...
- FDA Approves Susvimo (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration (AMD)on October 22, 2021 at 5:10 am
South San Francisco, CA -- October 22, 2021 -- 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 Susvimo (ranibizumab injection) 100 mg/mL for...
- FDA Expands Approval of Dupixent (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthmaon October 20, 2021 at 4:10 am
TARRYTOWN, N.Y. and PARIS, Oct. 20, 2021 /PRNewswire/ -- Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option Only biologic...
- FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Diseaseon October 18, 2021 at 10:10 pm
PRINCETON, N.J., Oct. 18, 2021 /PRNewswire/ -- Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced that the U.S. Food and Drug Administration (FDA) has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs...
- FDA Approves Seglentis (celecoxib and tramadol hydrochloride) for the Management of Acute Painon October 18, 2021 at 9:10 pm
October 18, 2021 -- The U.S. Food and Drug Administration (FDA) approved Seglentis (celecoxib and tramadol hydrochloride), a proprietary product developed by Esteve Pharmaceuticals' R&D team. It is an innovative first-in-class product comprised...
- FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdoseon October 18, 2021 at 8:10 pm
SAN DIEGO, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has approved Adamis’ Zimhi™ (naloxone HCL Injection, USP) 5 mg/0.5 mL...
- U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populationson October 18, 2021 at 3:10 am
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 18, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120...
- FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Canceron October 15, 2021 at 11:10 pm
Tecentriq is the first and only cancer immunotherapy approved for treatment of NSCLC in the adjuvant setting Approval based on the Phase III IMpower010 study showing adjuvant Tecentriq improved disease-free survival by more than one-third in...
- U.S. FDA Approves Cyltezo (adalimumab-adbm) as First Interchangeable Biosimilar with Humiraon October 15, 2021 at 11:10 pm
Regulatory approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s Phase III randomized VOLTAIRE-X clinical trial Data showed that switching several times between Cyltezo (adalimumab-adbm) and Humira...