Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S.
Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial
Company to host investor webcast on Dec. 11, 2024
For U.S. media and investors only DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Jazz Ph... Read more
Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation
Syndax to host conference call today at 6:00 p.m. ET WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor... Read more
First-ever FDA approval for gene therapy directly administered to the brain
Priority review voucher granted
Broad label including children and adults
PTC pioneers new approach for CNS drug delivery WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the... Read more
AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy)
Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALL
Conference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq:... Read more
SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly... Read more
Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies1-3
Patients on Scemblix also had fewer dose reductions and half the rate of adverse reactions leading to treatment discontinuation1-3
Nearly 50% of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue or switch therapies within one... Read more
Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis
Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer... Read more
ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades
Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid)... Read more
PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Estradiol Gel, 0.06%. ANI’s Estradiol Gel, 0.06% is the generic version of the reference listed drug (RLD) EstroGel® Gel, 0.06%.
"With the FDA approval and commercialization of Estradiol Gel,... Read more
First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter
Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve
Now with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today GALWAY, Ireland, Oct. 24, 2024 /PRNewswire/... Read more
First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50
Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV NEW YORK / Oct 22, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine,... Read more
Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis
The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024
SELARSDI’s U.S. launch for all indications is expected in Q1 2025 REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:... Read more
