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FDA biologics chief back 12 days after resigning, creating pressure on biotech stocks
The unexpected return of the FDA biologics leader shortly after stepping down has introduced uncertainty, leading to a decline in the valuation of various biotechnology companies w...
Read Full Article →Sarepta Therapeutics Stock Surges as FDA Allows Elevidys Sales to Resume
The approval to restart Elevidys sales has notably impacted Sarepta Therapeutics' market value, reflecting investor confidence and a positive shift in the company's financial outlo...
Read Full Article →FDA Clinical Hold on RP-A501 Trial Triggers Rocket Pharmaceuticals (RCKT) Stock Plunge and Class Act...
The FDA’s suspension of a key clinical study for Rocket Pharmaceuticals has led to a substantial decline in the company’s market value and the initiation of investor legal proceedi...
Read Full Article →Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments
The decision to stop shipments of the gene therapy in response to regulatory demands has led to a decline in shareholder confidence, impacting the company’s market valuation on Tue...
Read Full Article →Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug
The company’s shares declined further after it declined the regulatory agency’s request to remove its medication from the market, raising concerns about future revenue and investor...
Read Full Article →Sarepta stock extends decline as company declines FDA call to withdraw drug
Sarepta Therapeutics' shares continued to fall following the company's decision to reject the FDA’s request to remove a medication linked to multiple fatalities from the market.
Read Full Article →Sarepta drops another 5% to $13.37 after downgrades, FDA probe
The company’s shares declined significantly following reduced analyst ratings and an ongoing investigation by regulatory authorities, impacting investor confidence and market valua...
Read Full Article →Knockoff weight loss drugs were supposed to be 'gone and illegal.' Now they're bigger than ever
Despite regulatory efforts to eliminate counterfeit weight loss medications, compounding pharmacies have found a way to continue production, resulting in sustained market demand an...
Read Full Article →FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
The FDA’s new approach to factoring in drug affordability during voucher issuance may influence the overall cost dynamics and market access for medications pending regulatory appro...
Read Full Article →Biotech startups are facing a new threat
Recent reductions in government support and regulatory challenges have caused investors to become more cautious, potentially limiting financial resources available for emerging bio...
Read Full Article →FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient new...
The approval of Gilead’s biannual HIV prevention injection presents a significant development in treatment options, though its impact may be influenced by possible reductions in go...
Read Full Article →Hairmax Partners with Truemed to Accept FSA/HSA Payments on FDA-Cleared Laser Hair Growth Devices
The collaboration enables customers to utilize pre-tax health savings accounts for purchasing advanced FDA-approved hair restoration products, potentially increasing accessibility...
Read Full Article →Merck Gets FDA Approval to Expand Use of Its Top-Selling Drug, Keytruda
The recent FDA authorization to broaden the application of Merck's leading medication could potentially increase the company's revenue by accessing new patient populations and expa...
Read Full Article →FDA approves Merck’s RSV shot for infants, ramping up competition with Sanofi and AstraZeneca
Merck’s newly authorized RSV vaccine for infants is expected to impact the market by challenging established treatments, potentially influencing sales and market share among leadin...
Read Full Article →Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid...
The newly granted patent for Biofrontera’s updated topical treatment extends intellectual property rights until 2043, potentially securing long-term revenue streams and competitive...
Read Full Article →Moderna Stock Climbs as FDA Approves New COVID-19 Vaccine
The approval of Moderna's latest COVID-19 vaccine by the FDA has positively influenced investor confidence, leading to a notable rise in the company's share value in the stock mark...
Read Full Article →Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE
The FDA’s authorization of Moderna’s latest vaccine is expected to enhance the company’s market portfolio, potentially driving increased revenue streams and strengthening its compe...
Read Full Article →Levi & Korsinsky Launches Fraud Investigation on Behalf of Savara Inc. (SVRA) Shareholders
The initiation of a probe into potential legal breaches related to Savara Inc.'s recent regulatory setback may impact investor confidence and influence the company’s stock market p...
Read Full Article →Healthy Returns: Novavax scores narrower Covid vaccine approval after delay
The FDA’s conditional approval of Novavax’s Covid-19 vaccine, despite limitations, may influence the company’s market performance and future revenue potential within the competitiv...
Read Full Article →Moderna Stock Jumps on New FDA COVID-19 Booster Guidelines
The announcement of updated FDA recommendations for COVID-19 boosters led to a notable increase in Moderna’s share value, reflecting investor optimism about the company’s future re...
Read Full Article →Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction
The recent court decision enables Avadel Pharmaceuticals to continue advancing clinical studies and potentially secure regulatory clearance for its treatment, which could positivel...
Read Full Article →EU digital product passports won’t solve food fraud, but blockchain can
The implementation of self-sovereign identity technology is proposed as a more effective solution than the EU's digital product passports to combat food fraud and ensure product au...
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