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Upsher-Smith Enhances Generics Portfolio by Introducing Difluprednate Ophthalmic Emulsion

Emulsion 0.05%. According to IQVIA, the Difluprednate Ophthalmic Emulsion market had U.S. sales of approximately $18 million*. The Therapeutic Equivalence (TE) code for Upsher-Smith's Difluprednate Ophthalmic Emulsion product is AB, and the...

European Commission Approves Alteogen’s Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

macular degeneration." The EC approval was based on the Phase 3 clinical trials conducted by Alteogen Biologics in 12 countries, including Europe, South Korea and Japan from June 2022 to February 2024. The comparative clinical evaluation involving...

Sanguine Expands Oncology Biospecimen Portfolio via Strategic Clinic Partnerships

Sanguine Biosciences, a leading provider of healthy and disease-state human biospecimens and data for research, today announced the expansion of its oncology sample offerings through new partnerships with oncology clinics nationwide. These...

LOTUS study data on DAYBUE® (trofinetide) for Rett Syndrome's long-term efficacy and tolerability is published in Developmental Medicine and Child Neurology

syndrome, with early insights into managing gastrointestinal (GI) symptoms in the real world among patients receiving up to 12 months of treatment with DAYBUE. “These findings from LOTUS help deepen our understanding of the potential outcomes...

Optune Lua® from Novocure has received approval in Japan for treating unresectable advanced/recurrent Non-Small Cell Lung Cancer (NSCLC)

announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who...

At the American Thyroid Association meeting, FORE Biotherapeutics presented Phase 1/2a data for Plixorafenib, demonstrating a prolonged duration of effect in BRAF-altered thyroid cancers

therapies to treat patients with cancer, today presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that demonstrate treatment with plixorafenib in patients with BRAF-altered papillary thyroid cancer (PTC) and...

At the PHPN 2025 Symposium, Corsair Pharma will present new data on its proprietary transdermal system for Treprostinil prodrug

Transdermal System at the upcoming Pulmonary Hypertension Professional Network (PHPN) Symposium, taking place September 18–20, 2025, in Seattle, Washington. The presentation will feature preclinical pharmacokinetic and safety data for the TRX-248...

Medicines Discovery Catapult and Crown Bioscience form a global alliance for radiopharmaceutical innovation

showing the pre-clinical drug discovery pipeline for radiopharmaceuticals is attached. Adapted from Pharmaceutics 2023, 15(5), 1378 About Medicines Discovery Catapult Medicines Discovery Catapult (MDC) is a national Life Sciences service dedicated...

Marius Pharmaceuticals and Hims & Hers™ collaborate to expand access to KYZATREX® (testosterone undecanoate) CIII capsules, the first FDA-approved oral testosterone therapy available on the Hims & Hers platform

testosterone levels. In a clinical study, KYZATREX was proven to be up to 96% effective at restoring testosterone levels.1-3* On average, free testosterone doubled, giving study participants higher amounts of bioavailable testosterone.2,3 Higher...

Waldencast announces the FDA approval of Obagi® saypha® MagIQ™ injectable hyaluronic acid gel under the Obagi Medical brand

innovator in aesthetics, doubling Obagi Medical’s total addressable market to approximately $4.2 billion by 2029.1 “This milestone represents an exciting advancement in our long-term strategy to become the world’s leading dermatological megabrand...

At World Sleep 2025, Avadel Pharmaceuticals will present new data on LUMRYZ™ (sodium oxybate) for extended-release oral suspension

that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16 posters at World Sleep 2025, taking place September 5-10, in Singapore. "LUMRYZ's novel once-nightly delivery system means...

Nuvation Bio unveils new data on IBTROZI™ (taletrectinib) in advanced ROS1-positive non-small cell lung cancer

studies evaluating IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). “With additional follow-up time, these updated findings from the TRUST...

In the IDeate-Lung01 Phase 2 trial, Ifinatamab Deruxtecan demonstrated clinically meaningful response rates in patients with extensive-stage small cell lung cancer

Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These data were...

Precision BioSciences announces a U.S. patent covering PBGENE-HBV for chronic hepatitis B and provides updates on the program's status

develop in vivo gene editing therapies for diseases with high unmet need, announced that it will be issued U.S. Patent No. 12,410,418 by the U.S. Patent and Trademark Office on September 9, 2025, titled “Optimized engineered meganucleases having...

Boehringer Ingelheim launches swine vaccine with advanced protection against Porcine Circovirus Type 2 in the U.S

has observed a clear shift over the past decade, with PCV2d becoming the predominant genotype in the U.S. and globally.1,2 The broad protection provided by INGELVAC CIRCOFLEX® AD was designed with this shifting landscape in mind, advancing pig...

Experic appoints Jeffrey Shane as Chief Commercial Officer

strategic equipment partner. He has also been a member of Experic’s Board of Directors since the company’s launch in 2018. “We are delighted to welcome Jeffrey into this role,” said David Wood, Chairman & CEO of Experic. “His distinguished career...

Mytos announces partnerships with StemSight, Rinri Therapeutics, and Novadip to drive next-generation cell therapy trials

Mytos’ automation to support the production of their otic neural progenitor cell therapy. “As our lead product, Rincell-1 for sensorineural hearing loss, enters the clinic, manufacturing precision and consistency are critical,” said Dr. Terri...

Eisai submitted a rolling sBLA to the U.S. FDA for LEQEMBI® IQLIK™ as a subcutaneous starting dose to treat early Alzheimer’s, under Fast Track status

across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with early AD. Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250...

Sai Life Sciences afslutter fase II af produktionsblok 11 på Bidar-stedet i Indien og øger kapaciteten til 700 KL

and Manufacturing Organization (CRDMO), today announced the completion of Phase II of its new Production Block (PB-11) at the company’s flagship API manufacturing facility in Bidar, India (Unit IV). The Phase I of PB-11, with a capacity of 110 KL,...

Pharma Equity Groups datterselskab, Reponex Pharmaceuticals A/S, har fået godkendelse til at starte klinisk studie med RNX-011 mod livstruende peritonitis

at selskabet har modtaget myndighedsgodkendelse til at igangsætte et afgørende fase 2-studie med lægemiddelkandidaten RNX-011. Studiet skal undersøge behandling af sekundær peritonitis – en alvorlig og livstruende intra-abdominal infektion med høj...