BioPoint Inc

12/17/2025

Big pharmaceutical companies including AbbVie, Eli Lilly, J&J and Merck are urging the FDA to separate facility inspections from the drug approval review process so inspections can happen earlier and reduce delays or complete response letters tied to manufacturing issues. https://www.biospace.com/fda/big-pharma-pushes-fda-to-decouple-inspections-from-drug-approval-applications

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.

12/16/2025

Gilead’s investigational once-daily single-tablet bictegravir/lenacapavir HIV regimen matched the effectiveness of its current leading therapy in a second late-stage trial, keeping viral suppression in adults with HIV. https://www.fiercepharma.com/pharma/gileads-single-tablet-hiv-combo-bictegravir-lenacapavir-passes-another-late-stage-test-way

With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen. | With the investigational product, Gilead is targeting certain segments of the HIV market who are underserved by current...

12/15/2025

Milestone won FDA approval for Cardamyst, a fast-acting nasal spray patients can use to stop sudden PSVT episodes on their own. It’s the first new treatment for this heart-rhythm condition in decades and the company’s first approval in 22 years. https://www.fiercepharma.com/pharma/after-22-years-milestone-wins-fda-approval-nasal-spray-heart-arrythmia-condition-0

Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given Milestone Pharmaceuticals its first FDA approval in its 22-year history. | The FDA has signed off on Milestone Pharmaceuticals’ Cardamyst, a self-administered nasal spray to que...

12/12/2025

The FDA has expanded the label for GSK’s oral antibiotic Blujepa (gepotidacin) to include treatment of uncomplicated gonorrhea in people 12 and older, offering the first new class of antibiotic for this STI in over three decades and an alternative to injectable therapy. https://www.fiercepharma.com/pharma/gsk-gains-fda-expansion-antibiotic-blujepa-treatment-gonorrhea

With an increase in the antimicrobial resistance to therapies for gonorrhea, doctors have been left wi | With an increase in the antimicrobial resistance to therapies for gonorrhea, doctors have been left with fewer options to treat the sexually transmitted infection. Thursday, the FDA addressed the...

12/08/2025

Children with sickle cell disease and thalassemia are benefiting from Casgevy, a "national priority" drug. The positive clinical data may lead to expanded access through label expansion and increased commercial availability. https://www.biopharmadive.com/news/ASH-Vertex-Casgevy-childen-sickle-cell-thalassemia/807182/

Casgevy, now a "national priority" drug, helped kids with sickle cell and thalassemia, results which may help toward a label expansion and stronger commercial uptake.

12/05/2025

Praxis's stock soared 40% after the company announced encouraging results for two of its drug programs. Elsewhere, Bristol Myers secured approval for Breyanzi in a fifth cancer type, and AstraZeneca expanded its existing agreement in the rare disease space. https://www.biopharmadive.com/news/praxis-denali-breyanzi-kelun-crescent-astrazeneca-neurimmune/807098/

Praxis shares climbed another 40% on a pair of positive updates on two different drugs. Elsewhere, Bristol Myers’ Breyanzi was cleared for its fifth cancer indication and AstraZeneca expanded a rare disease deal.

12/04/2025

SciNeuro Pharmaceuticals is Arch's latest investment in the challenging field of nervous system drug development. https://www.biopharmadive.com/news/scineuro-biotech-arch-lav-capital-raise-neuro-drug/807076/

SciNeuro Pharmaceuticals represents the latest in a string of Arch investments directed at the nervous system, a notoriously challenging area of drug development.

12/03/2025

The company's stock has soared, quadrupling in value, fueled by the prospect of a breakthrough treatment. The drug, currently facing an FDA hurdle, could be the first to address heart complications in Duchenne muscular dystrophy, offering hope to patients. https://www.biopharmadive.com/news/capricor-duchenne-cell-therapy-trial-results-stock-shares/806931/

Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.

11/27/2025

11/25/2025

Delivered directly into the spinal fluid, Itvisma, a form of Zolgensma, can be used in patients of all ages (children, teens, and adults) to potentially stabilize or improve motor function. https://www.biopharmadive.com/news/fda-approve-novartis-sma-gene-therapy-itvisma-zolgensma-older-patients/806387/

Itvisma, an intrathecal version of Zolgensma, can be used in children, teens and adults to stabilize or improve motor function.

11/20/2025

The company did not comment on Gottlieb's appointment, which coincides with its ongoing efforts to improve relations with federal regulators. https://www.biopharmadive.com/news/unitedhealth-adds-scott-gottlieb-board-of-directors/805924/

The company declined to comment on Gottlieb’s appointment, which comes as it works to improve its relationship with federal regulators.

11/19/2025

While a bipartisan report warned of China's growing control over the pharmaceutical supply chain, the U.S. industry is also seeing activity. Alkermes sweetened its bid for Avadel, and Moderna is investing $140 million in domestic drug production. https://www.biopharmadive.com/news/alkermes-avadel-china-biotech-moderna-lifordi-vanda/805824/

A bipartisan report warned Congress about China’s growing control over the pharmaceutical supply chain. Elsewhere, Alkermes sweetened its bid for Avadel and Moderna is investing $140 million in U.S. drug production.