Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date PRINCETON, N.J. / Apr 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug A... Read more
Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo
UPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial
Advances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S.... Read more
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1
Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2
IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent proteinuria progress to kidney... Read more
FDA approves leading solution for latent tuberculosis diagnostics, advancing global effort to fight infectious diseases WALTHAM, Mass. / Apr 02, 2025 / Business Wire / Revvity, Inc. (NYSE: RVTY), today announced that the U.S. Food and Drug Administration (FDA) has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT™.TB test. Initially launched outside the U.S. in 2024, this powerful combination allows laboratories to improve productivity while maintaining... Read more
Based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Mar 31, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment... Read more
Qfitlia Becomes the Sixth Alnylam-Discovered RNAi Therapeutic Approved by U.S. FDA and First and Only to Treat Hemophilia A or B With or Without Inhibitors CAMBRIDGE, Mass. / Mar 28, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and Drug Administration’s (FDA) approval of Qfitlia™ (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in... Read more
First approved therapy to address hyperphagia in individuals with Prader-Willi syndrome
Management to host conference call and webcast today, March 26th, at 5:30pm ET REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline)... Read more
FDA approval based on the phase 3 CABINET pivotal trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo
CABOMETYX is now the first and only systemic treatment that is FDA approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression and functional status
Exelixis is prepared to immediately support these new in... Read more
Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years
Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from a recurrent episode
Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials PHILADELPHIA / Mar 25, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of... Read more
New, improved formulation set to replace EGRIFTA SV® MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize... Read more
Achieves Significant Milestone with Expanded Use Indication, Opens Sizable New SI Market Opportunity LOS GATOS, CA / ACCESS Newswire / March 24, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of an expanded indication for the Catamaran® SI Joint Fusion System... Read more
Phase III study showed sustained proteinuria reduction at one year with favorable safety1
Fabhalta is the only oral alternative complement pathway inhibitor thought to target the underlying cause of C3G1-3
C3G is an ultra-rare kidney disease typically diagnosed in young adults and often progresses to kidney failure2-4
Novartis continues to advance multiple kidney disease treatments with high unmet need, compounding capabilities and strengthening unique leadership... Read more
Novel Mechanism of Action Delivers Rapid Knockdown of Transthyretin, Addressing the Disease at its Source
Proven Consistency of Effect on Cardiovascular Outcomes, Function, and Quality of Life in ATTR-CM Population Representative of Today’s Patients
Only Therapeutic Approved in the U.S. to Address Both Cardiomyopathy and Polyneuropathy Manifestations of ATTR Amyloidosis
Alnylam Offers Multiple Programs to Support Broad and Seamless Patient Access; Majority of Patients... Read more
TREMFYA® is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen
Supported by data from the GALAXI study, TREMFYA® is the only IL-23i to show superiority versus STELARA® in all pooled endoscopic endpoints within a double-blinded registrational trial
TREMFYA® approval in Crohn's disease builds upon recent ulcerative colitis FDA approval, marking the fourth indication for... Read more
ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular edema (DME)
ANI plans to begin marketing ILUVIEN in the U.S. under the combined label later this year BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label... Read more
PRINCETON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format. This new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network. The prefilled... Read more
TNKase® (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years
Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care
Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase® (alteplase) SOUTH SAN FRANCISCO, Calif. / Mar 03, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today... Read more
New closed-loop system self-adjusts DBS therapy to individual brain activity in real time; the largest commercial launch of brain-computer interface technology ever GALWAY, Ireland, Feb. 24, 2025 /PRNewswire/ -- For the one million people diagnosed with Parkinson's disease in the United States1, Medtronic plc (NYSE:MDT), a global leader in healthcare technology, proudly announces U.S. Food and Drug Administration (FDA) approval of BrainSense™ Adaptive... Read more
CTEXLI is the first and only medication approved for the treatment of CTX in adults
Approval based on Phase 3 RESTORE study results
CTEXLI granted U.S. FDA Orphan Drug exclusivity for the treatment of CTX FOSTER CITY, Calif. / Feb 24, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous... Read more
Mesalamine 800 mg delayed-release tablets, referencing ASACOL HD®
Lenalidomide capsules, referencing REVLIMID® BRIDGEWATER, N.J. / Feb 19, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. Additionally, the... Read more
Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y)
Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults PHILADELPHIA / Feb 17, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) for... Read more
First Major Technological Breakthrough in Hyaluronic Acid Dermal Fillers in a Decade; U.S. Launch Planned in Q2 2025
Launch Establishes Evolus as a Multi-Product Performance Beauty Company and Expands Addressable Market by 78% NEWPORT BEACH, Calif. / Feb 13, 2025 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse™... Read more
Approval is based on positive data from the Phase 3 ECHELON-3 trial, which demonstrated ADCETRIS regimen reduced the risk of death by 37%, a statistically significant, clinically meaningful improvement in overall survival (OS), compared to lenalidomide and rituximab plus placebo ECHELON-3 is the first Phase 3 trial to demonstrate OS advantage over lenalidomide and rituximab plus placebo for patients with at least 2 prior lines of therapy with R/R diffuse large B-cell... Read more
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries
Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution
New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration SOUTH SAN FRANCISCO, Calif. / Feb 12, 2025 / Business Wire / Genentech, a member of the Roche... Read more
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN
Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile
SpringWorks granted rare pediatric disease priority review voucher by the FDA STAMFORD, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq:... Read more
EMBLAVEOTM is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the U.S. FDA to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria
Gram-negative bacterial infections represent a significant public health threat due to their ability to develop resistance to antimicrobial therapies
Antimicrobial resistance (AMR) could lead to over 39 million deaths worldwide by 2050, and new treatments... Read more
ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease
ONAPGO is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of OFF time
ONAPGO will be available in the U.S. in second quarter 2025 ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biop... Read more
Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)
With as few as two treatments per year, Susvimo may help people with DME maintain their vision
Approval marks the second indication for Susvimo in addition to wet, or neovascular age-related macular degeneration (AMD) SOUTH SAN FRANCISCO, Calif. / Feb 04, 2025 / Business Wire / Genentech, a member of the Roche Group... Read more
JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years
JOURNAVX is an effective and well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain BOSTON / Jan 30, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has... Read more
A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours
85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies
SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in head-to-head evaluation
SYMBRAVO incorporates... Read more
